Health Policy

Major changes in continuing board certification are occurring across medical specialties. On January 6, 2020, the American Board of Dermatology (ABD) launches its new web-based longitudinal assessment program called CertLink (https://abderm.mycertlink.org/).¹ This new platform is designed to eventually replace the sit-down, high-stakes, once-every-10-year medical knowledge examination that dermatologists take to remain board certified. With this alternative, every participating dermatologist will receive a batch of 13 web-based questions every quarter that he/she may answer at a convenient time and place. Questions are answered one at a time or in batches, depending on the test taker’s preference, and can be completed on home or office computers (and eventually on smartphones). Participating in this type of testing does not require shutting down practice, traveling to a test center, or paying for expensive board review courses. CertLink is designed to be convenient, affordable, and relevant to an individual’s practice.

How did the ABD arrive at CertLink?

The ABD launched its original Maintenance of Certification (MOC) program in 2006. Since then, newly board-certified dermatologists, recertifying dermatologists with time-limited certificates, and time-unlimited dermatologists who volunteered to participate in MOC have experienced the dermatology MOC program. In its first 10 years, the program was met with very mixed reviews. The program was designed to assess and promote competence in a 4-part framework, including professionalism; commitment to lifelong learning and self-assessment; demonstration of knowledge, judgment, and skills; and improvement in medical practice. All 4 are areas of rational pursuit for medical professionals seeking to perform and maintain the highest quality patient care possible. But there were problems. First iterations are rarely perfect, and dermatology MOC was no exception.

At the onset, the ABD chose to oversee the MOC requirements and remained hands off in the delivery of education, relying instead on other organizations to fulfill the ABD’s requirements. Unfortunately, with limited educational offerings available, many diplomates paid notable registration fees for each qualifying MOC activity. Quality improvement activities were a relatively new experience for dermatologists and were time consuming. Required medical record reviews were onerous, often requiring more than 35 data points to be collected per medical record reviewed. The limited number and limited diversity of educational offerings also created circumstances in which the material covered was not maximally relevant to many participants. When paying to answer questions about patient populations or procedure types never encountered by the dermatologist who purchased the particular MOC activity, many asked the question “How does this make me a better doctor?” They were right to ask.

Cost, time commitment to participate in MOC, and relevance to practice were 3 key areas of concern for many dermatologists. In response to internal and external MOC feedback, in 2015 the ABD took a hard look at its 10-year experience with MOC. While contemplating its next strategies, the ABD temporarily put its component 4—practice improvement—requirements on hold. After much review, the ABD decided to take over a notable portion of the education delivery. Its goal was to provide education that would fulfill MOC requirements in a more affordable, relevant, quicker, and easier manner.

First, the ABD made the decision to assume a more notable role as educator, in part to offer qualifying activities at no additional cost to diplomates. By taking on the role as educator, 3 major changes resulted: the way ABD approached quality improvement activities, partnership to initiate a question-of-the-week self-assessment program, and initiation of a longitudinal assessment strategy that resulted in this month’s launch of CertLink.

The ABD revolutionized its quality improvement requirements with the launch of its practice improvement modules made available through its website.² These modules utilize recently published clinical practice gaps in 5 dermatology subspecialty domains to fulfill the practice improvement requirements. Participants read a brief synopsis of the supporting literature explaining practice improvement recommendations found in the module. Next, they find 5 patients in their practice with the condition, medication, or process in question and review whether they provided the care supported by the best available evidence. No module requires more than 5 medical records to review, and no more than 3 questions are answered per medical record review. If review confirms that the care was appropriate, no further action is needed. If a care gap is identified, then participants implement changes and later remeasure practice to detect any change. This certification activity was incredibly popular with the thousands of diplomates who have participated thus far; more than 97% stated the modules were relevant to practice, 98% stated they would recommend the modules to fellow dermatologists, and nearly 25% reported the module helped to change their practice for the better (unpublished data, July 2019). Relevance had been restored.

The ABD worked closely with the American Academy of Dermatology (AAD) to develop new education for weekly self-assessment. The ABD created the content and delivered to the AAD the first year of material for what would become the most successful and popular dermatology CME activity in history: the AAD Question of the Week (QOW). Thousands of dermatologists are registered to receive the QOW, with very active weekly participation. Participants receive 1 self-assessment point and 0.25 CME credits for each attempted question, right or wrong. This quizzing tool also was educational, with explanation of right answers and wrong choices included. The average amount of time spent answering each question was approximately 40 seconds. American Academy of Dermatology members can participate in its QOW as a member benefit. Self-assessment is no longer a time- consuming or costly process.

What will be part of CertLink?

In addition to standard multiple-choice questions, there are many interesting elements to the CertLink program, such as article-based questions. At the beginning of each year, dermatologists select 8 articles from a list of those hosted by CertLink. These are recently published articles, chosen for their meaningfulness to practicing dermatologists. Each subsequent quarter, 2 of these articles are issued to the diplomate to read at his/her leisure. Once ready, participants launch and answer 2 questions about the key points of each article. The article-based questions were designed to help the practicing dermatologist stay up-to-date and relevant in personally chosen areas.

Diplomates are offered a chance to learn from any question that was missed, with explanations or resources provided to help them understand why the correct answer is correct. In this new learn-to-competence model, diplomates are not penalized the first time they answer a particular question incorrectly. Each is provided an opportunity to learn through the explanations given, and then in a future quarter, the dermatologist is given a second chance to answer a similarly themed question, with only that second chance counting toward his/her overall score.

Another unique aspect of CertLink is the allowance of time off from assessment. The ABD recognizes that life happens, and that intermittent time off from career-long assessment will be necessary to accommodate life events, including but not limited to maternity leave, other medical leave, or mental health breaks. Diplomates may take off up to 1 quarter of testing each year to accommodate such life events. Those who need extra time (beyond 1 quarter per year) would need to communicate directly with ABD to request. Those who continue to answer questions throughout the year will have their lowest-performing quarter dropped, to maximize fairness to all. Only the top 3 quarters of CertLink test performance will be counted each year when making certification status decisions. Those who take 1 quarter off will have their other 3 quarters counted toward their scoring.

How will CertLink measure performance?

At the onset of CertLink, there is no predetermined passing score. It will take a few years for the ABD psychometricians to determine an acceptable performance. Questions are written not to be tricky but rather to assess patient issues the dermatologist is likely to encounter in practice. Article-based questions are designed to assess the key points of important recent articles to advance the dermatologist’s practice.

Final Thoughts

In the end, the ABD approach to the new area of continuing certification centers on strategies to be relevant, inexpensive, and minimally disruptive to practice, and to teach to competence and advance practice by bringing forward articles that address key recent literature. We think it is a much better approach to dermatology continuing certification.

Major changes in continuing board certification are occurring across medical specialties. On January 6, 2020, the American Board of Dermatology (ABD) launches its new web-based longitudinal assessment program called CertLink (https://abderm.mycertlink.org/).¹ This new platform is designed to eventually replace the sit-down, high-stakes, once-every-10-year medical knowledge examination that dermatologists take to remain board certified. With this alternative, every participating dermatologist will receive a batch of 13 web-based questions every quarter that he/she may answer at a convenient time and place. Questions are answered one at a time or in batches, depending on the test taker’s preference, and can be completed on home or office computers (and eventually on smartphones). Participating in this type of testing does not require shutting down practice, traveling to a test center, or paying for expensive board review courses. CertLink is designed to be convenient, affordable, and relevant to an individual’s practice.

How did the ABD arrive at CertLink?

The ABD launched its original Maintenance of Certification (MOC) program in 2006. Since then, newly board-certified dermatologists, recertifying dermatologists with time-limited certificates, and time-unlimited dermatologists who volunteered to participate in MOC have experienced the dermatology MOC program. In its first 10 years, the program was met with very mixed reviews. The program was designed to assess and promote competence in a 4-part framework, including professionalism; commitment to lifelong learning and self-assessment; demonstration of knowledge, judgment, and skills; and improvement in medical practice. All 4 are areas of rational pursuit for medical professionals seeking to perform and maintain the highest quality patient care possible. But there were problems. First iterations are rarely perfect, and dermatology MOC was no exception.

At the onset, the ABD chose to oversee the MOC requirements and remained hands off in the delivery of education, relying instead on other organizations to fulfill the ABD’s requirements. Unfortunately, with limited educational offerings available, many diplomates paid notable registration fees for each qualifying MOC activity. Quality improvement activities were a relatively new experience for dermatologists and were time consuming. Required medical record reviews were onerous, often requiring more than 35 data points to be collected per medical record reviewed. The limited number and limited diversity of educational offerings also created circumstances in which the material covered was not maximally relevant to many participants. When paying to answer questions about patient populations or procedure types never encountered by the dermatologist who purchased the particular MOC activity, many asked the question “How does this make me a better doctor?” They were right to ask.

Cost, time commitment to participate in MOC, and relevance to practice were 3 key areas of concern for many dermatologists. In response to internal and external MOC feedback, in 2015 the ABD took a hard look at its 10-year experience with MOC. While contemplating its next strategies, the ABD temporarily put its component 4—practice improvement—requirements on hold. After much review, the ABD decided to take over a notable portion of the education delivery. Its goal was to provide education that would fulfill MOC requirements in a more affordable, relevant, quicker, and easier manner.

First, the ABD made the decision to assume a more notable role as educator, in part to offer qualifying activities at no additional cost to diplomates. By taking on the role as educator, 3 major changes resulted: the way ABD approached quality improvement activities, partnership to initiate a question-of-the-week self-assessment program, and initiation of a longitudinal assessment strategy that resulted in this month’s launch of CertLink.

The ABD revolutionized its quality improvement requirements with the launch of its practice improvement modules made available through its website.² These modules utilize recently published clinical practice gaps in 5 dermatology subspecialty domains to fulfill the practice improvement requirements. Participants read a brief synopsis of the supporting literature explaining practice improvement recommendations found in the module. Next, they find 5 patients in their practice with the condition, medication, or process in question and review whether they provided the care supported by the best available evidence. No module requires more than 5 medical records to review, and no more than 3 questions are answered per medical record review. If review confirms that the care was appropriate, no further action is needed. If a care gap is identified, then participants implement changes and later remeasure practice to detect any change. This certification activity was incredibly popular with the thousands of diplomates who have participated thus far; more than 97% stated the modules were relevant to practice, 98% stated they would recommend the modules to fellow dermatologists, and nearly 25% reported the module helped to change their practice for the better (unpublished data, July 2019). Relevance had been restored.

The ABD worked closely with the American Academy of Dermatology (AAD) to develop new education for weekly self-assessment. The ABD created the content and delivered to the AAD the first year of material for what would become the most successful and popular dermatology CME activity in history: the AAD Question of the Week (QOW). Thousands of dermatologists are registered to receive the QOW, with very active weekly participation. Participants receive 1 self-assessment point and 0.25 CME credits for each attempted question, right or wrong. This quizzing tool also was educational, with explanation of right answers and wrong choices included. The average amount of time spent answering each question was approximately 40 seconds. American Academy of Dermatology members can participate in its QOW as a member benefit. Self-assessment is no longer a time- consuming or costly process.

What will be part of CertLink?

In addition to standard multiple-choice questions, there are many interesting elements to the CertLink program, such as article-based questions. At the beginning of each year, dermatologists select 8 articles from a list of those hosted by CertLink. These are recently published articles, chosen for their meaningfulness to practicing dermatologists. Each subsequent quarter, 2 of these articles are issued to the diplomate to read at his/her leisure. Once ready, participants launch and answer 2 questions about the key points of each article. The article-based questions were designed to help the practicing dermatologist stay up-to-date and relevant in personally chosen areas.

Diplomates are offered a chance to learn from any question that was missed, with explanations or resources provided to help them understand why the correct answer is correct. In this new learn-to-competence model, diplomates are not penalized the first time they answer a particular question incorrectly. Each is provided an opportunity to learn through the explanations given, and then in a future quarter, the dermatologist is given a second chance to answer a similarly themed question, with only that second chance counting toward his/her overall score.

Another unique aspect of CertLink is the allowance of time off from assessment. The ABD recognizes that life happens, and that intermittent time off from career-long assessment will be necessary to accommodate life events, including but not limited to maternity leave, other medical leave, or mental health breaks. Diplomates may take off up to 1 quarter of testing each year to accommodate such life events. Those who need extra time (beyond 1 quarter per year) would need to communicate directly with ABD to request. Those who continue to answer questions throughout the year will have their lowest-performing quarter dropped, to maximize fairness to all. Only the top 3 quarters of CertLink test performance will be counted each year when making certification status decisions. Those who take 1 quarter off will have their other 3 quarters counted toward their scoring.

How will CertLink measure performance?

At the onset of CertLink, there is no predetermined passing score. It will take a few years for the ABD psychometricians to determine an acceptable performance. Questions are written not to be tricky but rather to assess patient issues the dermatologist is likely to encounter in practice. Article-based questions are designed to assess the key points of important recent articles to advance the dermatologist’s practice.

Final Thoughts

In the end, the ABD approach to the new area of continuing certification centers on strategies to be relevant, inexpensive, and minimally disruptive to practice, and to teach to competence and advance practice by bringing forward articles that address key recent literature. We think it is a much better approach to dermatology continuing certification.

Major changes in continuing board certification are occurring across medical specialties. On January 6, 2020, the American Board of Dermatology (ABD) launches its new web-based longitudinal assessment program called CertLink (https://abderm.mycertlink.org/).¹ This new platform is designed to eventually replace the sit-down, high-stakes, once-every-10-year medical knowledge examination that dermatologists take to remain board certified. With this alternative, every participating dermatologist will receive a batch of 13 web-based questions every quarter that he/she may answer at a convenient time and place. Questions are answered one at a time or in batches, depending on the test taker’s preference, and can be completed on home or office computers (and eventually on smartphones). Participating in this type of testing does not require shutting down practice, traveling to a test center, or paying for expensive board review courses. CertLink is designed to be convenient, affordable, and relevant to an individual’s practice.

How did the ABD arrive at CertLink?

The ABD launched its original Maintenance of Certification (MOC) program in 2006. Since then, newly board-certified dermatologists, recertifying dermatologists with time-limited certificates, and time-unlimited dermatologists who volunteered to participate in MOC have experienced the dermatology MOC program. In its first 10 years, the program was met with very mixed reviews. The program was designed to assess and promote competence in a 4-part framework, including professionalism; commitment to lifelong learning and self-assessment; demonstration of knowledge, judgment, and skills; and improvement in medical practice. All 4 are areas of rational pursuit for medical professionals seeking to perform and maintain the highest quality patient care possible. But there were problems. First iterations are rarely perfect, and dermatology MOC was no exception.

At the onset, the ABD chose to oversee the MOC requirements and remained hands off in the delivery of education, relying instead on other organizations to fulfill the ABD’s requirements. Unfortunately, with limited educational offerings available, many diplomates paid notable registration fees for each qualifying MOC activity. Quality improvement activities were a relatively new experience for dermatologists and were time consuming. Required medical record reviews were onerous, often requiring more than 35 data points to be collected per medical record reviewed. The limited number and limited diversity of educational offerings also created circumstances in which the material covered was not maximally relevant to many participants. When paying to answer questions about patient populations or procedure types never encountered by the dermatologist who purchased the particular MOC activity, many asked the question “How does this make me a better doctor?” They were right to ask.

Cost, time commitment to participate in MOC, and relevance to practice were 3 key areas of concern for many dermatologists. In response to internal and external MOC feedback, in 2015 the ABD took a hard look at its 10-year experience with MOC. While contemplating its next strategies, the ABD temporarily put its component 4—practice improvement—requirements on hold. After much review, the ABD decided to take over a notable portion of the education delivery. Its goal was to provide education that would fulfill MOC requirements in a more affordable, relevant, quicker, and easier manner.

First, the ABD made the decision to assume a more notable role as educator, in part to offer qualifying activities at no additional cost to diplomates. By taking on the role as educator, 3 major changes resulted: the way ABD approached quality improvement activities, partnership to initiate a question-of-the-week self-assessment program, and initiation of a longitudinal assessment strategy that resulted in this month’s launch of CertLink.

The ABD revolutionized its quality improvement requirements with the launch of its practice improvement modules made available through its website.² These modules utilize recently published clinical practice gaps in 5 dermatology subspecialty domains to fulfill the practice improvement requirements. Participants read a brief synopsis of the supporting literature explaining practice improvement recommendations found in the module. Next, they find 5 patients in their practice with the condition, medication, or process in question and review whether they provided the care supported by the best available evidence. No module requires more than 5 medical records to review, and no more than 3 questions are answered per medical record review. If review confirms that the care was appropriate, no further action is needed. If a care gap is identified, then participants implement changes and later remeasure practice to detect any change. This certification activity was incredibly popular with the thousands of diplomates who have participated thus far; more than 97% stated the modules were relevant to practice, 98% stated they would recommend the modules to fellow dermatologists, and nearly 25% reported the module helped to change their practice for the better (unpublished data, July 2019). Relevance had been restored.

The ABD worked closely with the American Academy of Dermatology (AAD) to develop new education for weekly self-assessment. The ABD created the content and delivered to the AAD the first year of material for what would become the most successful and popular dermatology CME activity in history: the AAD Question of the Week (QOW). Thousands of dermatologists are registered to receive the QOW, with very active weekly participation. Participants receive 1 self-assessment point and 0.25 CME credits for each attempted question, right or wrong. This quizzing tool also was educational, with explanation of right answers and wrong choices included. The average amount of time spent answering each question was approximately 40 seconds. American Academy of Dermatology members can participate in its QOW as a member benefit. Self-assessment is no longer a time- consuming or costly process.

What will be part of CertLink?

In addition to standard multiple-choice questions, there are many interesting elements to the CertLink program, such as article-based questions. At the beginning of each year, dermatologists select 8 articles from a list of those hosted by CertLink. These are recently published articles, chosen for their meaningfulness to practicing dermatologists. Each subsequent quarter, 2 of these articles are issued to the diplomate to read at his/her leisure. Once ready, participants launch and answer 2 questions about the key points of each article. The article-based questions were designed to help the practicing dermatologist stay up-to-date and relevant in personally chosen areas.

Diplomates are offered a chance to learn from any question that was missed, with explanations or resources provided to help them understand why the correct answer is correct. In this new learn-to-competence model, diplomates are not penalized the first time they answer a particular question incorrectly. Each is provided an opportunity to learn through the explanations given, and then in a future quarter, the dermatologist is given a second chance to answer a similarly themed question, with only that second chance counting toward his/her overall score.

Another unique aspect of CertLink is the allowance of time off from assessment. The ABD recognizes that life happens, and that intermittent time off from career-long assessment will be necessary to accommodate life events, including but not limited to maternity leave, other medical leave, or mental health breaks. Diplomates may take off up to 1 quarter of testing each year to accommodate such life events. Those who need extra time (beyond 1 quarter per year) would need to communicate directly with ABD to request. Those who continue to answer questions throughout the year will have their lowest-performing quarter dropped, to maximize fairness to all. Only the top 3 quarters of CertLink test performance will be counted each year when making certification status decisions. Those who take 1 quarter off will have their other 3 quarters counted toward their scoring.

How will CertLink measure performance?

At the onset of CertLink, there is no predetermined passing score. It will take a few years for the ABD psychometricians to determine an acceptable performance. Questions are written not to be tricky but rather to assess patient issues the dermatologist is likely to encounter in practice. Article-based questions are designed to assess the key points of important recent articles to advance the dermatologist’s practice.

Final Thoughts

In the end, the ABD approach to the new area of continuing certification centers on strategies to be relevant, inexpensive, and minimally disruptive to practice, and to teach to competence and advance practice by bringing forward articles that address key recent literature. We think it is a much better approach to dermatology continuing certification.

Providing high-quality, patient-centered health care is a top priority for the US Department of Veterans Affairs (VA) Veteran Health Administration (VHA), whose core mission is to improve the health and well-being of US veterans. Thus, news of long wait times for medical appointments in the VHA sparked intense national attention and debate and led to changes in senior management and legislative action. ¹ On August 8, 2014, President Bara c k Obama signed the Veterans Access, Choice, and Accountability Act of 2014, also known as the Choice Act, which provided an additional $16 billion in emergency spending over 3 years to improve veterans’ access to timely health care. ² The Choice Act sought to develop an integrated health care network that allowed qualified VHA patients to receive specific health care services in their communities delivered by non-VHA health care providers (HCPs) but paid for by the VHA. The Choice Act also laid out explicit criteria for how to prioritize who would be eligible for VHA-purchased civilian care: (1) veterans who could not get timely appointments at a VHA medical facility within 30 days of referral; or (2) veterans who lived > 40 miles from the closest VHA medical facility.

VHA decision makers seeking to improve care delivery also need to weigh trade-offs between alternative approaches to providing rapid access. For instance, increasing access to non-VHA HCPs may not always decrease wait times and could result in loss of continuity, limited care coordination, limited ability to ensure and enforce high-quality standards at the VHA, and other challenges.^3-6 Although the concerns and views of elected representatives, advocacy groups, and health system leaders are important, it is unknown whether these views and preferences align with those of veterans. Arguably, the range of views and concerns of informed veterans whose health is at stake should be particularly prominent in such policy decision making.

To identify the considerations that were most important to veterans regarding VHA policy around decreasing wait times, a study was designed to engage a group of veterans who were eligible for civilian care under the Choice Act. The study took place 1 year after the Choice Act was passed. Veterans were asked to focus on 2 related questions: First, how should funding be used for building VHA capacity (build) vs purchasing civilian care (buy)? Second, under what circumstances should civilian care be prioritized?

The aim of this paper is to describe democratic deliberation (DD), a specific method that engaged veteran patients in complex policy decisions around access to care. DD methods have been used increasingly in health care for developing policy guidance, setting priorities, providing advice on ethical dilemmas, weighing risk-benefit trade-offs, and determining decision-making authority.^7-12 For example, DD helped guide national policy for mammography screening for breast cancer in New Zealand.¹³ The Agency for Healthcare Research and Quality has completed a systematic review and a large, randomized experiment on best practices for carrying out public deliberation.^8,13,14 However, despite the potential value of this approach, there has been little use of deliberative methods within the VHA for the explicit purpose of informing veteran health care delivery.

This paper describes the experience engaging veterans by using DD methodology and informing VHA leadership about the results of those deliberations. The specific aims were to understand whether DD is an acceptable approach to use to engage patients in the medical services policy-making process within VHA and whether veterans are able to come to an informed consensus.

Methods

Engaging patients and incorporating their needs and concerns within the policy-making process may improve health system policies and make those policies more patient centered. Such engagement also could be a way to generate creative solutions. However, because health-system decisions often involve making difficult trade-offs, effectively obtaining patient population input on complex care delivery issues can be challenging.

Although surveys can provide intuitive, top-of-mind input from respondents, these opinions are generally not sufficient for resolving complex problems.¹⁵ Focus groups and interviews may produce results that are more in-depth than surveys, but these methods tend to elicit settled private preferences rather than opinions about what the community should do.¹⁶ DD, on the other hand, is designed to elicit deeply informed public opinions on complex, value-laden topics to develop recommendations and policies for a larger community.¹⁷ The goal is to find collective solutions to challenging social problems. DD achieves this by giving participants an opportunity to explore a topic in-depth, question experts, and engage peers in reason-based discussions.^18,19 This method has its roots in political science and has been used over several decades to successfully inform policy making on a broad array of topics nationally and internationally—from health research ethics in the US to nuclear and energy policy in Japan.^7,16,20,21 DD has been found to promote ownership of public programs and lend legitimacy to policy decisions, political institutions, and democracy itself.¹⁸

A single day (8 hours) DD session was convened, following a Citizens Jury model of deliberation, which brings veteran patients together to learn about a topic, ask questions of experts, deliberate with peers, and generate a “citizen’s report” that contains a set of recommendations (Table 1). An overview of the different models of DD and rationale for each can be found elsewhere.^8,15

Recruitment Considerations

A purposively selected sample of civilian care-eligible veterans from a midwestern VHA health care system (1 medical center and 3 community-based outpatient clinics [CBOCs]) were invited to the DD session. The targeted number of participants was 30. Female veterans, who comprise only 7% of the local veteran population, were oversampled to account for their potentially different health care needs and to create balance between males and females in the session. Oversampling for other characteristics was not possible due to the relatively small sample size. Based on prior experience,⁷ it was assumed that 70% of willing participants would attend the session; therefore 34 veterans were invited and 24 attended. Each participant received a $200 incentive in appreciation for their substantial time commitment and to offset transportation costs.

Background Materials

A packet with educational materials (Flesch-Kincaid Grade Level of 10.5) was mailed to participants about 2 weeks before the DD session. Participants were asked to review prior to attending the session. These materials described the session (eg, purpose, organizers, importance) and provided factual information about the Choice Act (eg, eligibility, out-of-pocket costs, travel pay, prescription drug policies).

Session Overview

The session was structured to accomplish the following goals: (1) Elicit participants’ opinions about access to health care and reasons for those opinions; (2) Provide in-depth education about the Choice Act through presentations and discussions with topical experts; and (3) Elicit reasoning and recommendations on both the criteria by which participants prioritize candidates for civilian care and how participants would allocate additional funding to improve access (ie, by building VHA capacity to deliver more timely health care vs purchasing health care from civilian HCPs).

Participants were asked to fill out a survey on arrival in the morning and were assigned to 1 of 3 tables or small groups. Each table had a facilitator who had extensive experience in qualitative data collection methods and guided the dialogue using a scripted protocol that they helped develop and refine. The facilitation materials drew from and used previously published studies.^22,23 Each facilitator audio recorded the sessions and took notes. Three experts presented during plenary education sessions. Presentations were designed to provide balanced factual information and included a veteran’s perspective. One presenter was a clinician on the project team, another was a local clinical leader responsible for making decisions about what services to provide via civilian care (buy) vs enhancing the local VHA health system’s ability to provide those services (build), and the third presenter was a veteran who was on the project team.

Education Session 1

The first plenary education session with expert presentations was conducted after each table completed an icebreaker exercise. The project team physician provided a brief history and description of the Choice Act to reinforce educational materials sent to participants prior to the session. The health system clinical leader described his decision process and principles and highlighted constraints placed on him by the Choice Act that were in place at the time of the DD session. He also described existing local and national programs to provide civilian care (eg, local fee-basis non-VHA care programs) and how these programs sought to achieve goals similar to the Choice Act. The veteran presenter focused on the importance of session participants providing candid insight and observations and emphasized that this session was a significant opportunity to “have their voices heard.”

Deliberation 1: What criteria should be used to prioritize patients for receiving civilian care paid for by the VHA? To elicit preferences on the central question of this deliberation, participants were presented with 8 real-world cases that were based on interviews conducted with Choice Act-eligible veterans (Table 2 and eAppendices A

Education Session 2

In the second plenary session, the project team physician provided information about health care access issues, both inside and outside of the VHA, particularly between urban and rural areas. He also discussed factors related to the insufficient capacity to meet growing demand that contributed to the VHA wait-time crisis. The veteran presenter shared reflections on health care access from a veteran’s perspective.

Deliberation 2: How should additional funding be divided between increasing the ability of the VHA to (1) provide care by VHA HCPs; and (2) pay for care from non-VHA civilian HCPs? Participants were presented the patient examples and Choice Act funding scenarios (the buy policy option) and contrasted that with a build policy option. Participants were explicitly encouraged to shift their perspectives from thinking about individual cases to considering policy-level decisions and the broader social good (Table 2).

Ensuring Robust Deliberations

If participants do not adequately grasp the complexities of the topic, a deliberation can fail. To facilitate nuanced reasoning, real-world concrete examples were developed as the starting point of each deliberation based on interviews with actual patients (deliberation 1) and actual policy proposals relevant to the funding allocation decisions within the Choice Act (deliberation 2).

A deliberation also can fail with self-silencing, where participants withhold opinions that differ from those articulated first or by more vocal members of the group.²⁴ To combat self-silencing, highly experienced facilitators were used to ensure sharing from all participants and to support an open-minded, courteous, and reason-based environment for discourse. It was specified that the best solutions are achieved through reason-based and cordial disagreement and that success can be undermined when participants simply agree because it is easier or more comfortable.

A third way a deliberation can fail is if individuals do not adopt a group or system-level perspective. To counter this, facilitators reinforced at multiple points the importance of taking a broader social perspective rather than sharing only one’s personal preferences.

Finally, it is important to assess the quality of the deliberative process itself, to ensure that results are trustworthy.²⁵ To assess the quality of the deliberative process, participants knowledge about key issues pre- and postdeliberation were assessed. Participants also were asked to rate the quality of the facilitators and how well they felt their voice was heard and respected, and facilitators made qualitative assessments about the extent to which participants were engaged in reason-based and collaborative discussion.

Data

Quantitative data were collected via pre- and postsession surveys. The surveys contained items related to knowledge about the Choice Act, expectations for the DD session, beliefs and opinions about the provision of health care for veterans, recommended funding allocations between build vs buy policy options, and general demographics. Qualitative data were collected through detailed notes taken by the 3 facilitators. Each table’s deliberations were audio recorded so that gaps in the notes could be filled.

The 3 facilitators, who were all experienced qualitative researchers, typed their written notes into a template immediately after the session. Two of the 3 facilitators led the analysis of the session notes. Findings within and across the 3 deliberation tables were developed using content and matrix analysis methods.²⁶ Descriptive statistics were generated from survey responses and compared survey items pre- and postsession using paired t tests or χ² tests for categorical responses.

Results

Thirty-three percent of individuals invited (n = 127) agreed to participate. Those who declined cited conflicts related to distance, transportation, work/school, medical appointments, family commitments, or were not interested. In all, 24 (69%) of the 35 veterans who accepted the invitation attended the deliberation session. Of the 11 who accepted but did not attend, 5 cancelled ahead of time because of conflicts (Figure). Most participants were male (70%), 48% were aged 61 to 75 years, 65% were white, 43% had some college education, 43% reported an annual income of between $25,000 and $40,000, and only 35% reported very good health (eAppendix D).

Deliberation 1

During the deliberation on the prioritization criteria, the concept of “condition severity” emerged as an important criterion for veterans. This criterion captured simultaneous consideration of both clinical necessity and burden on the veteran to obtain care. For example, participants felt that patients with a life-threatening illness should be prioritized for civilian care over patients who need preventative or primary care (clinical necessity) and that elderly patients with substantial difficulty traveling to VHA appointments should be prioritized over patients who can travel more easily (burden). The Choice Act regulations at the time of the DD session did not reflect this nuanced perspective, stipulating only that veterans must live > 40 miles from the nearest VHA medical facility.

One of the 3 groups did not prioritize the patient cases because some members felt that no veteran should be constrained from receiving civilian care if they desired it. Nonetheless, this group did agree with prioritizing the first 2 cases in Table 3. The other groups prioritized all 8 cases in generally similar ways.

Deliberation 2

No clear consensus emerged on the buy vs build question. A representative from each table presented their group’s positions, rationale, and recommendations after deliberations were completed. After hearing the range of positions, the groups then had another opportunity to deliberate based on what they heard from the other tables; no new recommendations or consensus emerged.

Participants who were in favor of allocating more funds toward the build policy offered a range of rationales, saying that it would (1) increase access for rural veterans by building CBOCs and deploying more mobile units that could bring outlets for health care closer to their home communities; (2) provide critical and unique medical expertise to address veteran-specific issues such as prosthetics, traumatic brain injury, posttraumatic stress disorder, spinal cord injury, and shrapnel wounds that are typically not available through civilian providers; (3) give VHA more oversight over the quality and cost of care, which is more challenging to do with civilian providers; and (4) Improve VHA infrastructure by, for example, upgrading technology and attracting the best clinicians and staff to support “our VHA.”

Participants who were in favor of allocating more funds toward the buy policy also offered a range of rationales, saying that it would (1) decrease patient burden by increasing access through community providers, decreasing wait time, and lessening personal cost and travel time; (2) allow more patients to receive civilian care, which was generally seen as beneficial by a few participants because of perceptions that the VHA provides lower quality care due to a shortage of VHA providers, run-down/older facilities, lack of technology, and poorer-quality VHA providers; and (3) provide an opportunity to divest of costly facilities and invest in other innovative approaches. Regarding this last reason, a few participants felt that the VHA is “gouged” when building medical centers that overrun budgets. They also were concerned that investing in facilities tied VHA to specific locations when current locations of veterans may change “25 years from now.”

Survey Results

Twenty-three of the 24 participants completed both pre- and postsession surveys. The majority of participants in the session felt people in the group respected their opinion (96%); felt that the facilitator did not try to influence the group with her own opinions (96%); indicated they understood the information enough to participate as much as they wanted (100%); and were hopeful that their reasoning and recommendations would help inform VHA policy makers (82%).

The surveys also provided an opportunity to examine the extent to which knowledge, attitudes, and opinions changed from before to after the deliberation. Even with the small sample, responses revealed a trend toward improved knowledge about key elements of the Choice Act and its goals. Further, there was a shift in some participants’ opinions about how patients should be prioritized to receive civilian care. For example, before the deliberation participants generally felt that all veterans should be able to receive civilian care, whereas postdeliberation this was not the case. Postdeliberation, most participants felt that primary care should not be a high priority for civilian care but continued to endorse prioritizing civilian care for specialty services like orthopedic or cardiology-related care. Finally, participants moved from more diverse recommendations regarding additional funds allocations, toward consensus after the deliberation around allocating funds to the build policy. Eight participants supported a build policy beforehand, whereas 16 supported this policy afterward.

Discussion

This study explored DD as a method for deeply engaging veterans in complex policy making to guide funding allocation and prioritization decisions related to the Choice Act, decisions that are still very relevant today within the context of the Mission Act and have substantial implications for how health care is delivered in the VHA. The Mission Act passed on June 6, 2018, with the goal of improving access to and the reliability of civilian or community care for eligible veterans.²⁷ Decisions related to appropriating scarce funding to improve access to care is an emotional and value-laden topic that elicited strong and divergent opinions among the participants. Veterans were eager to have their voices heard and had strong expectations that VHA leadership would be briefed about their recommendations. The majority of participants were satisfied with the deliberation process, felt they understood the issues, and felt their opinions were respected. They expressed feelings of comradery and community throughout the process.

In this single deliberation session, the groups did not achieve a single, final consensus regarding how VHA funding should ultimately be allocated between buy and build policy options. Nonetheless, participants provided a rich array of recommendations and rationale for them. Session moderators observed rich, sophisticated, fair, and reason-based discussions on this complex topic. Participants left with a deeper knowledge and appreciation for the complex trade-offs and expressed strong rationales for both sides of the policy debate on build vs buy. In addition, the project yielded results of high interest to VHA policy makers.

This work was presented in multiple venues between 2015 to 2016, and to both local and national VHA leadership, including the local Executive Quality Leadership Boards, the VHA Central Office Committee on the Future State of VA Community Care, the VA Office of Patient Centered Care, and the National Veteran Experience Committee. Through these discussions and others, we saw great interest within the VHA system and high-level leaders to explore ways to include veterans’ voices in the policy-making process. This work was invaluable to our research team (eAppendix E 

Many health system decisions regarding what care should be delivered (and how) involve making difficult, value-laden choices in the context of limited resources. DD methods can be used to target and obtain specific viewpoints from diverse populations, such as the informed perspectives of minority and underrepresented populations within the VHA.¹⁹ For example, female veterans were oversampled to ensure that the informed preferences of this population was obtained. Thus, DD methods could provide a valuable tool for health systems to elicit in-depth diverse patient input on high-profile policies that will have a substantial impact on the system’s patient population.

Limitations

One potential downside of DD is that, because of the resource-intensive nature of deliberation sessions, they are often conducted with relatively small groups.⁹ Viewpoints of those within these small samples who are willing to spend an entire day discussing a complex topic may not be representative of the larger patient community. However, the core goal of DD is diversity of opinions rather than representativeness.

A stratified random sampling strategy that oversampled for underrepresented and minority populations was used to help select a diverse group that represents the population on key characteristics and partially addresses concern about representativeness. Efforts to optimize participation rates, including providing monetary incentives, also are helpful and have led to high participation rates in past deliberations.⁷

Health system communication strategies that promote the importance of becoming involved in DD sessions also may be helpful in improving rates of recruitment. On particularly important topics where health system leaders feel a larger resource investment is justified, conducting larger scale deliberations with many small groups may obtain more generalizable evidence about what individual patients and groups of patients recommend.⁷ However, due to the inherent limitations of surveys and focus group approaches for obtaining informed views on complex topics, there are no clear systematic alternatives to the DD approach.

Conclusion

DD is an effective method to meaningfully engage patients in deep deliberations to guide complex policy making. Although design of deliberative sessions is resource-intensive, patient engagement efforts, such as those described in this paper, could be an important aspect of a well-functioning learning health system. Further research into alternative, streamlined methods that can also engage veterans more deeply is needed. DD also can be combined with other approaches to broaden and confirm findings, including focus groups, town hall meetings, or surveys.

Although this study did not provide consensus on how the VHA should allocate funds with respect to the Choice Act, it did provide insight into the importance and feasibility of engaging veterans in the policy-making process. As more policies aimed at improving veterans’ access to civilian care are created, such as the most recent Mission Act, policy makers should strongly consider using the DD method of obtaining informed veteran input into future policy decisions.

Acknowledgments
Funding was provided by the US Department of Veterans Affairs Office of Analytics and Business Intelligence (OABI) and the VA Quality Enhancement Research Initiative (QUERI). Dr. Caverly was supported in part by a VA Career Development Award (CDA 16-151). Dr. Krein is supported by a VA Health Services Research and Development Research Career Scientist Award (RCS 11-222). The authors thank the veterans who participated in this work. They also thank Caitlin Reardon and Natalya Wawrin for their assistance in organizing the deliberation session.

Providing high-quality, patient-centered health care is a top priority for the US Department of Veterans Affairs (VA) Veteran Health Administration (VHA), whose core mission is to improve the health and well-being of US veterans. Thus, news of long wait times for medical appointments in the VHA sparked intense national attention and debate and led to changes in senior management and legislative action. ¹ On August 8, 2014, President Bara c k Obama signed the Veterans Access, Choice, and Accountability Act of 2014, also known as the Choice Act, which provided an additional $16 billion in emergency spending over 3 years to improve veterans’ access to timely health care. ² The Choice Act sought to develop an integrated health care network that allowed qualified VHA patients to receive specific health care services in their communities delivered by non-VHA health care providers (HCPs) but paid for by the VHA. The Choice Act also laid out explicit criteria for how to prioritize who would be eligible for VHA-purchased civilian care: (1) veterans who could not get timely appointments at a VHA medical facility within 30 days of referral; or (2) veterans who lived > 40 miles from the closest VHA medical facility.

VHA decision makers seeking to improve care delivery also need to weigh trade-offs between alternative approaches to providing rapid access. For instance, increasing access to non-VHA HCPs may not always decrease wait times and could result in loss of continuity, limited care coordination, limited ability to ensure and enforce high-quality standards at the VHA, and other challenges.^3-6 Although the concerns and views of elected representatives, advocacy groups, and health system leaders are important, it is unknown whether these views and preferences align with those of veterans. Arguably, the range of views and concerns of informed veterans whose health is at stake should be particularly prominent in such policy decision making.

To identify the considerations that were most important to veterans regarding VHA policy around decreasing wait times, a study was designed to engage a group of veterans who were eligible for civilian care under the Choice Act. The study took place 1 year after the Choice Act was passed. Veterans were asked to focus on 2 related questions: First, how should funding be used for building VHA capacity (build) vs purchasing civilian care (buy)? Second, under what circumstances should civilian care be prioritized?

The aim of this paper is to describe democratic deliberation (DD), a specific method that engaged veteran patients in complex policy decisions around access to care. DD methods have been used increasingly in health care for developing policy guidance, setting priorities, providing advice on ethical dilemmas, weighing risk-benefit trade-offs, and determining decision-making authority.^7-12 For example, DD helped guide national policy for mammography screening for breast cancer in New Zealand.¹³ The Agency for Healthcare Research and Quality has completed a systematic review and a large, randomized experiment on best practices for carrying out public deliberation.^8,13,14 However, despite the potential value of this approach, there has been little use of deliberative methods within the VHA for the explicit purpose of informing veteran health care delivery.

This paper describes the experience engaging veterans by using DD methodology and informing VHA leadership about the results of those deliberations. The specific aims were to understand whether DD is an acceptable approach to use to engage patients in the medical services policy-making process within VHA and whether veterans are able to come to an informed consensus.

Methods

Engaging patients and incorporating their needs and concerns within the policy-making process may improve health system policies and make those policies more patient centered. Such engagement also could be a way to generate creative solutions. However, because health-system decisions often involve making difficult trade-offs, effectively obtaining patient population input on complex care delivery issues can be challenging.

Although surveys can provide intuitive, top-of-mind input from respondents, these opinions are generally not sufficient for resolving complex problems.¹⁵ Focus groups and interviews may produce results that are more in-depth than surveys, but these methods tend to elicit settled private preferences rather than opinions about what the community should do.¹⁶ DD, on the other hand, is designed to elicit deeply informed public opinions on complex, value-laden topics to develop recommendations and policies for a larger community.¹⁷ The goal is to find collective solutions to challenging social problems. DD achieves this by giving participants an opportunity to explore a topic in-depth, question experts, and engage peers in reason-based discussions.^18,19 This method has its roots in political science and has been used over several decades to successfully inform policy making on a broad array of topics nationally and internationally—from health research ethics in the US to nuclear and energy policy in Japan.^7,16,20,21 DD has been found to promote ownership of public programs and lend legitimacy to policy decisions, political institutions, and democracy itself.¹⁸

A single day (8 hours) DD session was convened, following a Citizens Jury model of deliberation, which brings veteran patients together to learn about a topic, ask questions of experts, deliberate with peers, and generate a “citizen’s report” that contains a set of recommendations (Table 1). An overview of the different models of DD and rationale for each can be found elsewhere.^8,15

Recruitment Considerations

A purposively selected sample of civilian care-eligible veterans from a midwestern VHA health care system (1 medical center and 3 community-based outpatient clinics [CBOCs]) were invited to the DD session. The targeted number of participants was 30. Female veterans, who comprise only 7% of the local veteran population, were oversampled to account for their potentially different health care needs and to create balance between males and females in the session. Oversampling for other characteristics was not possible due to the relatively small sample size. Based on prior experience,⁷ it was assumed that 70% of willing participants would attend the session; therefore 34 veterans were invited and 24 attended. Each participant received a $200 incentive in appreciation for their substantial time commitment and to offset transportation costs.

Background Materials

A packet with educational materials (Flesch-Kincaid Grade Level of 10.5) was mailed to participants about 2 weeks before the DD session. Participants were asked to review prior to attending the session. These materials described the session (eg, purpose, organizers, importance) and provided factual information about the Choice Act (eg, eligibility, out-of-pocket costs, travel pay, prescription drug policies).

Session Overview

The session was structured to accomplish the following goals: (1) Elicit participants’ opinions about access to health care and reasons for those opinions; (2) Provide in-depth education about the Choice Act through presentations and discussions with topical experts; and (3) Elicit reasoning and recommendations on both the criteria by which participants prioritize candidates for civilian care and how participants would allocate additional funding to improve access (ie, by building VHA capacity to deliver more timely health care vs purchasing health care from civilian HCPs).

Participants were asked to fill out a survey on arrival in the morning and were assigned to 1 of 3 tables or small groups. Each table had a facilitator who had extensive experience in qualitative data collection methods and guided the dialogue using a scripted protocol that they helped develop and refine. The facilitation materials drew from and used previously published studies.^22,23 Each facilitator audio recorded the sessions and took notes. Three experts presented during plenary education sessions. Presentations were designed to provide balanced factual information and included a veteran’s perspective. One presenter was a clinician on the project team, another was a local clinical leader responsible for making decisions about what services to provide via civilian care (buy) vs enhancing the local VHA health system’s ability to provide those services (build), and the third presenter was a veteran who was on the project team.

Education Session 1

The first plenary education session with expert presentations was conducted after each table completed an icebreaker exercise. The project team physician provided a brief history and description of the Choice Act to reinforce educational materials sent to participants prior to the session. The health system clinical leader described his decision process and principles and highlighted constraints placed on him by the Choice Act that were in place at the time of the DD session. He also described existing local and national programs to provide civilian care (eg, local fee-basis non-VHA care programs) and how these programs sought to achieve goals similar to the Choice Act. The veteran presenter focused on the importance of session participants providing candid insight and observations and emphasized that this session was a significant opportunity to “have their voices heard.”

Deliberation 1: What criteria should be used to prioritize patients for receiving civilian care paid for by the VHA? To elicit preferences on the central question of this deliberation, participants were presented with 8 real-world cases that were based on interviews conducted with Choice Act-eligible veterans (Table 2 and eAppendices A

Education Session 2

In the second plenary session, the project team physician provided information about health care access issues, both inside and outside of the VHA, particularly between urban and rural areas. He also discussed factors related to the insufficient capacity to meet growing demand that contributed to the VHA wait-time crisis. The veteran presenter shared reflections on health care access from a veteran’s perspective.

Deliberation 2: How should additional funding be divided between increasing the ability of the VHA to (1) provide care by VHA HCPs; and (2) pay for care from non-VHA civilian HCPs? Participants were presented the patient examples and Choice Act funding scenarios (the buy policy option) and contrasted that with a build policy option. Participants were explicitly encouraged to shift their perspectives from thinking about individual cases to considering policy-level decisions and the broader social good (Table 2).

Ensuring Robust Deliberations

If participants do not adequately grasp the complexities of the topic, a deliberation can fail. To facilitate nuanced reasoning, real-world concrete examples were developed as the starting point of each deliberation based on interviews with actual patients (deliberation 1) and actual policy proposals relevant to the funding allocation decisions within the Choice Act (deliberation 2).

A deliberation also can fail with self-silencing, where participants withhold opinions that differ from those articulated first or by more vocal members of the group.²⁴ To combat self-silencing, highly experienced facilitators were used to ensure sharing from all participants and to support an open-minded, courteous, and reason-based environment for discourse. It was specified that the best solutions are achieved through reason-based and cordial disagreement and that success can be undermined when participants simply agree because it is easier or more comfortable.

A third way a deliberation can fail is if individuals do not adopt a group or system-level perspective. To counter this, facilitators reinforced at multiple points the importance of taking a broader social perspective rather than sharing only one’s personal preferences.

Finally, it is important to assess the quality of the deliberative process itself, to ensure that results are trustworthy.²⁵ To assess the quality of the deliberative process, participants knowledge about key issues pre- and postdeliberation were assessed. Participants also were asked to rate the quality of the facilitators and how well they felt their voice was heard and respected, and facilitators made qualitative assessments about the extent to which participants were engaged in reason-based and collaborative discussion.

Data

Quantitative data were collected via pre- and postsession surveys. The surveys contained items related to knowledge about the Choice Act, expectations for the DD session, beliefs and opinions about the provision of health care for veterans, recommended funding allocations between build vs buy policy options, and general demographics. Qualitative data were collected through detailed notes taken by the 3 facilitators. Each table’s deliberations were audio recorded so that gaps in the notes could be filled.

The 3 facilitators, who were all experienced qualitative researchers, typed their written notes into a template immediately after the session. Two of the 3 facilitators led the analysis of the session notes. Findings within and across the 3 deliberation tables were developed using content and matrix analysis methods.²⁶ Descriptive statistics were generated from survey responses and compared survey items pre- and postsession using paired t tests or χ² tests for categorical responses.

Results

Thirty-three percent of individuals invited (n = 127) agreed to participate. Those who declined cited conflicts related to distance, transportation, work/school, medical appointments, family commitments, or were not interested. In all, 24 (69%) of the 35 veterans who accepted the invitation attended the deliberation session. Of the 11 who accepted but did not attend, 5 cancelled ahead of time because of conflicts (Figure). Most participants were male (70%), 48% were aged 61 to 75 years, 65% were white, 43% had some college education, 43% reported an annual income of between $25,000 and $40,000, and only 35% reported very good health (eAppendix D).

Deliberation 1

During the deliberation on the prioritization criteria, the concept of “condition severity” emerged as an important criterion for veterans. This criterion captured simultaneous consideration of both clinical necessity and burden on the veteran to obtain care. For example, participants felt that patients with a life-threatening illness should be prioritized for civilian care over patients who need preventative or primary care (clinical necessity) and that elderly patients with substantial difficulty traveling to VHA appointments should be prioritized over patients who can travel more easily (burden). The Choice Act regulations at the time of the DD session did not reflect this nuanced perspective, stipulating only that veterans must live > 40 miles from the nearest VHA medical facility.

One of the 3 groups did not prioritize the patient cases because some members felt that no veteran should be constrained from receiving civilian care if they desired it. Nonetheless, this group did agree with prioritizing the first 2 cases in Table 3. The other groups prioritized all 8 cases in generally similar ways.

Deliberation 2

No clear consensus emerged on the buy vs build question. A representative from each table presented their group’s positions, rationale, and recommendations after deliberations were completed. After hearing the range of positions, the groups then had another opportunity to deliberate based on what they heard from the other tables; no new recommendations or consensus emerged.

Participants who were in favor of allocating more funds toward the build policy offered a range of rationales, saying that it would (1) increase access for rural veterans by building CBOCs and deploying more mobile units that could bring outlets for health care closer to their home communities; (2) provide critical and unique medical expertise to address veteran-specific issues such as prosthetics, traumatic brain injury, posttraumatic stress disorder, spinal cord injury, and shrapnel wounds that are typically not available through civilian providers; (3) give VHA more oversight over the quality and cost of care, which is more challenging to do with civilian providers; and (4) Improve VHA infrastructure by, for example, upgrading technology and attracting the best clinicians and staff to support “our VHA.”

Participants who were in favor of allocating more funds toward the buy policy also offered a range of rationales, saying that it would (1) decrease patient burden by increasing access through community providers, decreasing wait time, and lessening personal cost and travel time; (2) allow more patients to receive civilian care, which was generally seen as beneficial by a few participants because of perceptions that the VHA provides lower quality care due to a shortage of VHA providers, run-down/older facilities, lack of technology, and poorer-quality VHA providers; and (3) provide an opportunity to divest of costly facilities and invest in other innovative approaches. Regarding this last reason, a few participants felt that the VHA is “gouged” when building medical centers that overrun budgets. They also were concerned that investing in facilities tied VHA to specific locations when current locations of veterans may change “25 years from now.”

Survey Results

Twenty-three of the 24 participants completed both pre- and postsession surveys. The majority of participants in the session felt people in the group respected their opinion (96%); felt that the facilitator did not try to influence the group with her own opinions (96%); indicated they understood the information enough to participate as much as they wanted (100%); and were hopeful that their reasoning and recommendations would help inform VHA policy makers (82%).

The surveys also provided an opportunity to examine the extent to which knowledge, attitudes, and opinions changed from before to after the deliberation. Even with the small sample, responses revealed a trend toward improved knowledge about key elements of the Choice Act and its goals. Further, there was a shift in some participants’ opinions about how patients should be prioritized to receive civilian care. For example, before the deliberation participants generally felt that all veterans should be able to receive civilian care, whereas postdeliberation this was not the case. Postdeliberation, most participants felt that primary care should not be a high priority for civilian care but continued to endorse prioritizing civilian care for specialty services like orthopedic or cardiology-related care. Finally, participants moved from more diverse recommendations regarding additional funds allocations, toward consensus after the deliberation around allocating funds to the build policy. Eight participants supported a build policy beforehand, whereas 16 supported this policy afterward.

Discussion

This study explored DD as a method for deeply engaging veterans in complex policy making to guide funding allocation and prioritization decisions related to the Choice Act, decisions that are still very relevant today within the context of the Mission Act and have substantial implications for how health care is delivered in the VHA. The Mission Act passed on June 6, 2018, with the goal of improving access to and the reliability of civilian or community care for eligible veterans.²⁷ Decisions related to appropriating scarce funding to improve access to care is an emotional and value-laden topic that elicited strong and divergent opinions among the participants. Veterans were eager to have their voices heard and had strong expectations that VHA leadership would be briefed about their recommendations. The majority of participants were satisfied with the deliberation process, felt they understood the issues, and felt their opinions were respected. They expressed feelings of comradery and community throughout the process.

In this single deliberation session, the groups did not achieve a single, final consensus regarding how VHA funding should ultimately be allocated between buy and build policy options. Nonetheless, participants provided a rich array of recommendations and rationale for them. Session moderators observed rich, sophisticated, fair, and reason-based discussions on this complex topic. Participants left with a deeper knowledge and appreciation for the complex trade-offs and expressed strong rationales for both sides of the policy debate on build vs buy. In addition, the project yielded results of high interest to VHA policy makers.

This work was presented in multiple venues between 2015 to 2016, and to both local and national VHA leadership, including the local Executive Quality Leadership Boards, the VHA Central Office Committee on the Future State of VA Community Care, the VA Office of Patient Centered Care, and the National Veteran Experience Committee. Through these discussions and others, we saw great interest within the VHA system and high-level leaders to explore ways to include veterans’ voices in the policy-making process. This work was invaluable to our research team (eAppendix E 

Many health system decisions regarding what care should be delivered (and how) involve making difficult, value-laden choices in the context of limited resources. DD methods can be used to target and obtain specific viewpoints from diverse populations, such as the informed perspectives of minority and underrepresented populations within the VHA.¹⁹ For example, female veterans were oversampled to ensure that the informed preferences of this population was obtained. Thus, DD methods could provide a valuable tool for health systems to elicit in-depth diverse patient input on high-profile policies that will have a substantial impact on the system’s patient population.

Limitations

One potential downside of DD is that, because of the resource-intensive nature of deliberation sessions, they are often conducted with relatively small groups.⁹ Viewpoints of those within these small samples who are willing to spend an entire day discussing a complex topic may not be representative of the larger patient community. However, the core goal of DD is diversity of opinions rather than representativeness.

A stratified random sampling strategy that oversampled for underrepresented and minority populations was used to help select a diverse group that represents the population on key characteristics and partially addresses concern about representativeness. Efforts to optimize participation rates, including providing monetary incentives, also are helpful and have led to high participation rates in past deliberations.⁷

Health system communication strategies that promote the importance of becoming involved in DD sessions also may be helpful in improving rates of recruitment. On particularly important topics where health system leaders feel a larger resource investment is justified, conducting larger scale deliberations with many small groups may obtain more generalizable evidence about what individual patients and groups of patients recommend.⁷ However, due to the inherent limitations of surveys and focus group approaches for obtaining informed views on complex topics, there are no clear systematic alternatives to the DD approach.

Conclusion

DD is an effective method to meaningfully engage patients in deep deliberations to guide complex policy making. Although design of deliberative sessions is resource-intensive, patient engagement efforts, such as those described in this paper, could be an important aspect of a well-functioning learning health system. Further research into alternative, streamlined methods that can also engage veterans more deeply is needed. DD also can be combined with other approaches to broaden and confirm findings, including focus groups, town hall meetings, or surveys.

Although this study did not provide consensus on how the VHA should allocate funds with respect to the Choice Act, it did provide insight into the importance and feasibility of engaging veterans in the policy-making process. As more policies aimed at improving veterans’ access to civilian care are created, such as the most recent Mission Act, policy makers should strongly consider using the DD method of obtaining informed veteran input into future policy decisions.

Acknowledgments
Funding was provided by the US Department of Veterans Affairs Office of Analytics and Business Intelligence (OABI) and the VA Quality Enhancement Research Initiative (QUERI). Dr. Caverly was supported in part by a VA Career Development Award (CDA 16-151). Dr. Krein is supported by a VA Health Services Research and Development Research Career Scientist Award (RCS 11-222). The authors thank the veterans who participated in this work. They also thank Caitlin Reardon and Natalya Wawrin for their assistance in organizing the deliberation session.

Providing high-quality, patient-centered health care is a top priority for the US Department of Veterans Affairs (VA) Veteran Health Administration (VHA), whose core mission is to improve the health and well-being of US veterans. Thus, news of long wait times for medical appointments in the VHA sparked intense national attention and debate and led to changes in senior management and legislative action. ¹ On August 8, 2014, President Bara c k Obama signed the Veterans Access, Choice, and Accountability Act of 2014, also known as the Choice Act, which provided an additional $16 billion in emergency spending over 3 years to improve veterans’ access to timely health care. ² The Choice Act sought to develop an integrated health care network that allowed qualified VHA patients to receive specific health care services in their communities delivered by non-VHA health care providers (HCPs) but paid for by the VHA. The Choice Act also laid out explicit criteria for how to prioritize who would be eligible for VHA-purchased civilian care: (1) veterans who could not get timely appointments at a VHA medical facility within 30 days of referral; or (2) veterans who lived > 40 miles from the closest VHA medical facility.

VHA decision makers seeking to improve care delivery also need to weigh trade-offs between alternative approaches to providing rapid access. For instance, increasing access to non-VHA HCPs may not always decrease wait times and could result in loss of continuity, limited care coordination, limited ability to ensure and enforce high-quality standards at the VHA, and other challenges.^3-6 Although the concerns and views of elected representatives, advocacy groups, and health system leaders are important, it is unknown whether these views and preferences align with those of veterans. Arguably, the range of views and concerns of informed veterans whose health is at stake should be particularly prominent in such policy decision making.

To identify the considerations that were most important to veterans regarding VHA policy around decreasing wait times, a study was designed to engage a group of veterans who were eligible for civilian care under the Choice Act. The study took place 1 year after the Choice Act was passed. Veterans were asked to focus on 2 related questions: First, how should funding be used for building VHA capacity (build) vs purchasing civilian care (buy)? Second, under what circumstances should civilian care be prioritized?

The aim of this paper is to describe democratic deliberation (DD), a specific method that engaged veteran patients in complex policy decisions around access to care. DD methods have been used increasingly in health care for developing policy guidance, setting priorities, providing advice on ethical dilemmas, weighing risk-benefit trade-offs, and determining decision-making authority.^7-12 For example, DD helped guide national policy for mammography screening for breast cancer in New Zealand.¹³ The Agency for Healthcare Research and Quality has completed a systematic review and a large, randomized experiment on best practices for carrying out public deliberation.^8,13,14 However, despite the potential value of this approach, there has been little use of deliberative methods within the VHA for the explicit purpose of informing veteran health care delivery.

This paper describes the experience engaging veterans by using DD methodology and informing VHA leadership about the results of those deliberations. The specific aims were to understand whether DD is an acceptable approach to use to engage patients in the medical services policy-making process within VHA and whether veterans are able to come to an informed consensus.

Methods

Engaging patients and incorporating their needs and concerns within the policy-making process may improve health system policies and make those policies more patient centered. Such engagement also could be a way to generate creative solutions. However, because health-system decisions often involve making difficult trade-offs, effectively obtaining patient population input on complex care delivery issues can be challenging.

Although surveys can provide intuitive, top-of-mind input from respondents, these opinions are generally not sufficient for resolving complex problems.¹⁵ Focus groups and interviews may produce results that are more in-depth than surveys, but these methods tend to elicit settled private preferences rather than opinions about what the community should do.¹⁶ DD, on the other hand, is designed to elicit deeply informed public opinions on complex, value-laden topics to develop recommendations and policies for a larger community.¹⁷ The goal is to find collective solutions to challenging social problems. DD achieves this by giving participants an opportunity to explore a topic in-depth, question experts, and engage peers in reason-based discussions.^18,19 This method has its roots in political science and has been used over several decades to successfully inform policy making on a broad array of topics nationally and internationally—from health research ethics in the US to nuclear and energy policy in Japan.^7,16,20,21 DD has been found to promote ownership of public programs and lend legitimacy to policy decisions, political institutions, and democracy itself.¹⁸

A single day (8 hours) DD session was convened, following a Citizens Jury model of deliberation, which brings veteran patients together to learn about a topic, ask questions of experts, deliberate with peers, and generate a “citizen’s report” that contains a set of recommendations (Table 1). An overview of the different models of DD and rationale for each can be found elsewhere.^8,15

Recruitment Considerations

A purposively selected sample of civilian care-eligible veterans from a midwestern VHA health care system (1 medical center and 3 community-based outpatient clinics [CBOCs]) were invited to the DD session. The targeted number of participants was 30. Female veterans, who comprise only 7% of the local veteran population, were oversampled to account for their potentially different health care needs and to create balance between males and females in the session. Oversampling for other characteristics was not possible due to the relatively small sample size. Based on prior experience,⁷ it was assumed that 70% of willing participants would attend the session; therefore 34 veterans were invited and 24 attended. Each participant received a $200 incentive in appreciation for their substantial time commitment and to offset transportation costs.

Background Materials

A packet with educational materials (Flesch-Kincaid Grade Level of 10.5) was mailed to participants about 2 weeks before the DD session. Participants were asked to review prior to attending the session. These materials described the session (eg, purpose, organizers, importance) and provided factual information about the Choice Act (eg, eligibility, out-of-pocket costs, travel pay, prescription drug policies).

Session Overview

The session was structured to accomplish the following goals: (1) Elicit participants’ opinions about access to health care and reasons for those opinions; (2) Provide in-depth education about the Choice Act through presentations and discussions with topical experts; and (3) Elicit reasoning and recommendations on both the criteria by which participants prioritize candidates for civilian care and how participants would allocate additional funding to improve access (ie, by building VHA capacity to deliver more timely health care vs purchasing health care from civilian HCPs).

Participants were asked to fill out a survey on arrival in the morning and were assigned to 1 of 3 tables or small groups. Each table had a facilitator who had extensive experience in qualitative data collection methods and guided the dialogue using a scripted protocol that they helped develop and refine. The facilitation materials drew from and used previously published studies.^22,23 Each facilitator audio recorded the sessions and took notes. Three experts presented during plenary education sessions. Presentations were designed to provide balanced factual information and included a veteran’s perspective. One presenter was a clinician on the project team, another was a local clinical leader responsible for making decisions about what services to provide via civilian care (buy) vs enhancing the local VHA health system’s ability to provide those services (build), and the third presenter was a veteran who was on the project team.

Education Session 1

The first plenary education session with expert presentations was conducted after each table completed an icebreaker exercise. The project team physician provided a brief history and description of the Choice Act to reinforce educational materials sent to participants prior to the session. The health system clinical leader described his decision process and principles and highlighted constraints placed on him by the Choice Act that were in place at the time of the DD session. He also described existing local and national programs to provide civilian care (eg, local fee-basis non-VHA care programs) and how these programs sought to achieve goals similar to the Choice Act. The veteran presenter focused on the importance of session participants providing candid insight and observations and emphasized that this session was a significant opportunity to “have their voices heard.”

Deliberation 1: What criteria should be used to prioritize patients for receiving civilian care paid for by the VHA? To elicit preferences on the central question of this deliberation, participants were presented with 8 real-world cases that were based on interviews conducted with Choice Act-eligible veterans (Table 2 and eAppendices A

Education Session 2

In the second plenary session, the project team physician provided information about health care access issues, both inside and outside of the VHA, particularly between urban and rural areas. He also discussed factors related to the insufficient capacity to meet growing demand that contributed to the VHA wait-time crisis. The veteran presenter shared reflections on health care access from a veteran’s perspective.

Deliberation 2: How should additional funding be divided between increasing the ability of the VHA to (1) provide care by VHA HCPs; and (2) pay for care from non-VHA civilian HCPs? Participants were presented the patient examples and Choice Act funding scenarios (the buy policy option) and contrasted that with a build policy option. Participants were explicitly encouraged to shift their perspectives from thinking about individual cases to considering policy-level decisions and the broader social good (Table 2).

Ensuring Robust Deliberations

If participants do not adequately grasp the complexities of the topic, a deliberation can fail. To facilitate nuanced reasoning, real-world concrete examples were developed as the starting point of each deliberation based on interviews with actual patients (deliberation 1) and actual policy proposals relevant to the funding allocation decisions within the Choice Act (deliberation 2).

A deliberation also can fail with self-silencing, where participants withhold opinions that differ from those articulated first or by more vocal members of the group.²⁴ To combat self-silencing, highly experienced facilitators were used to ensure sharing from all participants and to support an open-minded, courteous, and reason-based environment for discourse. It was specified that the best solutions are achieved through reason-based and cordial disagreement and that success can be undermined when participants simply agree because it is easier or more comfortable.

A third way a deliberation can fail is if individuals do not adopt a group or system-level perspective. To counter this, facilitators reinforced at multiple points the importance of taking a broader social perspective rather than sharing only one’s personal preferences.

Finally, it is important to assess the quality of the deliberative process itself, to ensure that results are trustworthy.²⁵ To assess the quality of the deliberative process, participants knowledge about key issues pre- and postdeliberation were assessed. Participants also were asked to rate the quality of the facilitators and how well they felt their voice was heard and respected, and facilitators made qualitative assessments about the extent to which participants were engaged in reason-based and collaborative discussion.

Data

Quantitative data were collected via pre- and postsession surveys. The surveys contained items related to knowledge about the Choice Act, expectations for the DD session, beliefs and opinions about the provision of health care for veterans, recommended funding allocations between build vs buy policy options, and general demographics. Qualitative data were collected through detailed notes taken by the 3 facilitators. Each table’s deliberations were audio recorded so that gaps in the notes could be filled.

The 3 facilitators, who were all experienced qualitative researchers, typed their written notes into a template immediately after the session. Two of the 3 facilitators led the analysis of the session notes. Findings within and across the 3 deliberation tables were developed using content and matrix analysis methods.²⁶ Descriptive statistics were generated from survey responses and compared survey items pre- and postsession using paired t tests or χ² tests for categorical responses.

Results

Thirty-three percent of individuals invited (n = 127) agreed to participate. Those who declined cited conflicts related to distance, transportation, work/school, medical appointments, family commitments, or were not interested. In all, 24 (69%) of the 35 veterans who accepted the invitation attended the deliberation session. Of the 11 who accepted but did not attend, 5 cancelled ahead of time because of conflicts (Figure). Most participants were male (70%), 48% were aged 61 to 75 years, 65% were white, 43% had some college education, 43% reported an annual income of between $25,000 and $40,000, and only 35% reported very good health (eAppendix D).

Deliberation 1

During the deliberation on the prioritization criteria, the concept of “condition severity” emerged as an important criterion for veterans. This criterion captured simultaneous consideration of both clinical necessity and burden on the veteran to obtain care. For example, participants felt that patients with a life-threatening illness should be prioritized for civilian care over patients who need preventative or primary care (clinical necessity) and that elderly patients with substantial difficulty traveling to VHA appointments should be prioritized over patients who can travel more easily (burden). The Choice Act regulations at the time of the DD session did not reflect this nuanced perspective, stipulating only that veterans must live > 40 miles from the nearest VHA medical facility.

One of the 3 groups did not prioritize the patient cases because some members felt that no veteran should be constrained from receiving civilian care if they desired it. Nonetheless, this group did agree with prioritizing the first 2 cases in Table 3. The other groups prioritized all 8 cases in generally similar ways.

Deliberation 2

No clear consensus emerged on the buy vs build question. A representative from each table presented their group’s positions, rationale, and recommendations after deliberations were completed. After hearing the range of positions, the groups then had another opportunity to deliberate based on what they heard from the other tables; no new recommendations or consensus emerged.

Participants who were in favor of allocating more funds toward the build policy offered a range of rationales, saying that it would (1) increase access for rural veterans by building CBOCs and deploying more mobile units that could bring outlets for health care closer to their home communities; (2) provide critical and unique medical expertise to address veteran-specific issues such as prosthetics, traumatic brain injury, posttraumatic stress disorder, spinal cord injury, and shrapnel wounds that are typically not available through civilian providers; (3) give VHA more oversight over the quality and cost of care, which is more challenging to do with civilian providers; and (4) Improve VHA infrastructure by, for example, upgrading technology and attracting the best clinicians and staff to support “our VHA.”

Participants who were in favor of allocating more funds toward the buy policy also offered a range of rationales, saying that it would (1) decrease patient burden by increasing access through community providers, decreasing wait time, and lessening personal cost and travel time; (2) allow more patients to receive civilian care, which was generally seen as beneficial by a few participants because of perceptions that the VHA provides lower quality care due to a shortage of VHA providers, run-down/older facilities, lack of technology, and poorer-quality VHA providers; and (3) provide an opportunity to divest of costly facilities and invest in other innovative approaches. Regarding this last reason, a few participants felt that the VHA is “gouged” when building medical centers that overrun budgets. They also were concerned that investing in facilities tied VHA to specific locations when current locations of veterans may change “25 years from now.”

Survey Results

Twenty-three of the 24 participants completed both pre- and postsession surveys. The majority of participants in the session felt people in the group respected their opinion (96%); felt that the facilitator did not try to influence the group with her own opinions (96%); indicated they understood the information enough to participate as much as they wanted (100%); and were hopeful that their reasoning and recommendations would help inform VHA policy makers (82%).

The surveys also provided an opportunity to examine the extent to which knowledge, attitudes, and opinions changed from before to after the deliberation. Even with the small sample, responses revealed a trend toward improved knowledge about key elements of the Choice Act and its goals. Further, there was a shift in some participants’ opinions about how patients should be prioritized to receive civilian care. For example, before the deliberation participants generally felt that all veterans should be able to receive civilian care, whereas postdeliberation this was not the case. Postdeliberation, most participants felt that primary care should not be a high priority for civilian care but continued to endorse prioritizing civilian care for specialty services like orthopedic or cardiology-related care. Finally, participants moved from more diverse recommendations regarding additional funds allocations, toward consensus after the deliberation around allocating funds to the build policy. Eight participants supported a build policy beforehand, whereas 16 supported this policy afterward.

Discussion

This study explored DD as a method for deeply engaging veterans in complex policy making to guide funding allocation and prioritization decisions related to the Choice Act, decisions that are still very relevant today within the context of the Mission Act and have substantial implications for how health care is delivered in the VHA. The Mission Act passed on June 6, 2018, with the goal of improving access to and the reliability of civilian or community care for eligible veterans.²⁷ Decisions related to appropriating scarce funding to improve access to care is an emotional and value-laden topic that elicited strong and divergent opinions among the participants. Veterans were eager to have their voices heard and had strong expectations that VHA leadership would be briefed about their recommendations. The majority of participants were satisfied with the deliberation process, felt they understood the issues, and felt their opinions were respected. They expressed feelings of comradery and community throughout the process.

In this single deliberation session, the groups did not achieve a single, final consensus regarding how VHA funding should ultimately be allocated between buy and build policy options. Nonetheless, participants provided a rich array of recommendations and rationale for them. Session moderators observed rich, sophisticated, fair, and reason-based discussions on this complex topic. Participants left with a deeper knowledge and appreciation for the complex trade-offs and expressed strong rationales for both sides of the policy debate on build vs buy. In addition, the project yielded results of high interest to VHA policy makers.

This work was presented in multiple venues between 2015 to 2016, and to both local and national VHA leadership, including the local Executive Quality Leadership Boards, the VHA Central Office Committee on the Future State of VA Community Care, the VA Office of Patient Centered Care, and the National Veteran Experience Committee. Through these discussions and others, we saw great interest within the VHA system and high-level leaders to explore ways to include veterans’ voices in the policy-making process. This work was invaluable to our research team (eAppendix E 

Many health system decisions regarding what care should be delivered (and how) involve making difficult, value-laden choices in the context of limited resources. DD methods can be used to target and obtain specific viewpoints from diverse populations, such as the informed perspectives of minority and underrepresented populations within the VHA.¹⁹ For example, female veterans were oversampled to ensure that the informed preferences of this population was obtained. Thus, DD methods could provide a valuable tool for health systems to elicit in-depth diverse patient input on high-profile policies that will have a substantial impact on the system’s patient population.

Limitations

One potential downside of DD is that, because of the resource-intensive nature of deliberation sessions, they are often conducted with relatively small groups.⁹ Viewpoints of those within these small samples who are willing to spend an entire day discussing a complex topic may not be representative of the larger patient community. However, the core goal of DD is diversity of opinions rather than representativeness.

A stratified random sampling strategy that oversampled for underrepresented and minority populations was used to help select a diverse group that represents the population on key characteristics and partially addresses concern about representativeness. Efforts to optimize participation rates, including providing monetary incentives, also are helpful and have led to high participation rates in past deliberations.⁷

Health system communication strategies that promote the importance of becoming involved in DD sessions also may be helpful in improving rates of recruitment. On particularly important topics where health system leaders feel a larger resource investment is justified, conducting larger scale deliberations with many small groups may obtain more generalizable evidence about what individual patients and groups of patients recommend.⁷ However, due to the inherent limitations of surveys and focus group approaches for obtaining informed views on complex topics, there are no clear systematic alternatives to the DD approach.

Conclusion

DD is an effective method to meaningfully engage patients in deep deliberations to guide complex policy making. Although design of deliberative sessions is resource-intensive, patient engagement efforts, such as those described in this paper, could be an important aspect of a well-functioning learning health system. Further research into alternative, streamlined methods that can also engage veterans more deeply is needed. DD also can be combined with other approaches to broaden and confirm findings, including focus groups, town hall meetings, or surveys.

Although this study did not provide consensus on how the VHA should allocate funds with respect to the Choice Act, it did provide insight into the importance and feasibility of engaging veterans in the policy-making process. As more policies aimed at improving veterans’ access to civilian care are created, such as the most recent Mission Act, policy makers should strongly consider using the DD method of obtaining informed veteran input into future policy decisions.

Acknowledgments
Funding was provided by the US Department of Veterans Affairs Office of Analytics and Business Intelligence (OABI) and the VA Quality Enhancement Research Initiative (QUERI). Dr. Caverly was supported in part by a VA Career Development Award (CDA 16-151). Dr. Krein is supported by a VA Health Services Research and Development Research Career Scientist Award (RCS 11-222). The authors thank the veterans who participated in this work. They also thank Caitlin Reardon and Natalya Wawrin for their assistance in organizing the deliberation session.

Nearly 1 in 8 households—and 1 in 6 households with children—experienced food insecurity in 2017, defined as limited or uncertain availability of nutritionally adequate and safe foods.¹ Food insecurity is often even more pronounced among households with individuals with acute or chronic medical conditions.^2-6 Moreover, food insecurity is independently associated with a range of adverse health outcomes, including poorer control of diabetes mellitus, hypertension, depression and other major psychiatric disorders, HIV, and chronic lung and kidney disease, as well as poorer overall health status.^7-14 Food insecurity also has been associated with increased health care costs and acute care utilization as well as increased probability of delayed or missed care.^15-19

The relationship between food insecurity and poor health outcomes is a complex and often cyclic phenomenon (Figure 1). Poor nutritional status is fueled by limited access to healthful foods as well as increased reliance on calorie-dense and nutrient-poor “junk” foods, which are less expensive and often more readily available in low-income neighborhoods.^5,20-24 These compensatory dietary patterns place individuals at higher risk for developing cardiometabolic conditions and for poor control of these conditions.^{5,8,9,12,25,26} Additionally, the physiological and psychological stressors of food insecurity may precipitate depression and anxiety or worsen existing mental health conditions, resulting in feelings of overwhelm and decreased self-management capacity.^5,8,27-31 Food insecurity has further been associated with poor sleep, declines in cognitive function, and increased falls, particularly among the frail and elderly.^32-34

Prevalence and Importance of Food Insecurity Among US Veterans

Nearly 1.5 million veterans in the US are living below the federal poverty level (FPL).³⁹ An additional 2.4 million veterans are living paycheck to paycheck at < 200% of the FPL.⁴⁰ Veterans living in poverty are at even higher risk than nonveterans for food insecurity, homelessness, and other material hardship.⁴¹

Estimates of food insecurity among veterans vary widely, ranging from 6% to 24%—nearly twice that of the general US population.^8,42-45 Higher rates of food insecurity have been reported among certain high-risk subgroups, including veterans who served in Iraq and Afghanistan (27%), female veterans (28%), homeless and formerly homeless veterans (49%), and veterans with serious mental illness (35%).^6,32,43,46 Additional risk factors for food insecurity specific to veteran populations include younger age, having recently left active-duty military service, and lower final military paygrade.^42,45-47 As in the general population, veteran food insecurity is associated with a range of adverse health outcomes, including poorer overall health status as well as increased probability of delayed or missed care.^{6,8,32,42-44,46}

Even among veterans enrolled in federal food assistance programs, many still struggle to afford nutritionally adequate foods. As one example, in a study of mostly male homeless and formerly homeless veterans, O’Toole and colleagues found that nearly half of those reporting food insecurity were already receiving federal food assistance benefits, and 22% relied on emergency food resources.³² Of households served by Feeding America food pantries and meal programs, 20% have a member who has served in the US military.⁴⁸

Federal Programs To Address Food Insecurity

There are several important federal food assistance programs designed to help alleviate food insecurity. The Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp program) is the largest federal food assistance program and provides low-income Americans with cash benefits to purchase food. SNAP has been shown to substantially reduce food insecurity.^7,49 The program also is associated with significant decreases in cost-related medication nonadherence as well as reductions in health care costs and both acute care and nursing home utilization.^16,50-54 Although nearly 1.4 million veterans live in SNAP-enrolled households, 59% of eligible veterans are not enrolled.^43,55 Closing this SNAP eligibility-enrollment gap, has been a focus of recent efforts to improve long-term food security among veterans. There also are several federal food assistance programs for households with children, including the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and school meals programs. Among federal nutrition programs for seniors, the Older American’s Act contains designated funding to support nutrition services for older adults, including congregate meal programs in community settings like senior centers, places of worship, and housing communities, and home-delivered meals through programs like Meals on Wheels.⁵⁶

VHA Response to Food Insecurity

The Veterans Health Administration (VHA) is the country’s largest integrated, federally funded health care system.⁵⁷ In November 2015, congressional briefings on veteran food insecurity organized by the national non-profit organization MAZON: A Jewish Response to Hunger and hosted with bipartisan support were provided to the US House and Senate. As a result of these briefings, VHA chartered the national Ensuring Veteran Food Security Workgroup with a mandate to partner with governmental and nonprofit agencies to “focus on the issue of food insecurity, the identification of veterans at risk, the needed training of VHA staff and the coordination of resources and initiatives to support the veterans for whom we care.” Building off a pilot in US Department of Veterans Affairs (VA) Homeless Patient Aligned Care Teams (H-PACTs),³² VHA subsequently integrated a single-item food insecurity screening tool into the VA electronic health record (EHR) clinical reminder system (Figure 2). The clinical reminder, which was rolled out across VA medical centers nationally in October 2017, provides an alert to screen all noninstitutionalized veterans for food insecurity. To date, nearly 5 million veterans have been screened. When a veteran endorses food insecurity based on the initial screening question, a prompt appears to offer the veteran a referral to a social worker and/or dietitian. Positive screening results also should be communicated to the patient’s primary care provider. Depending on site-specific clinical flow, the reminders are typically completed in the outpatient setting either by nurses or medical assistants during intake or by providers as part of the clinical visit. However, any member of the health care team can complete the clinical reminder at any time. As of September 2019, approximately 74,000 veterans have been identified as food insecure.⁵⁸

Addressing Food Insecurity

VHA has been a recognized leader in addressing homelessness and other social determinants of health through its integrated care and PACT delivery models.^59-61 The food insecurity clinical reminder was designed to facilitate a tailored, interdisciplinary approach to identify and address food insecurity. Interdisciplinary care team members—including medical assistants, clinicians, social workers, registered dietitians, nurse care managers, occupational or physical therapists, and pharmacists—are uniquely positioned to identify veterans impacted by food insecurity, assess for associated clinical and/or social risk factors, and offer appropriate medical and nutrition interventions and resource referrals.

This interdisciplinary team-based model is essential given the range of potential drivers underlying veteran experiences of food insecurity and subsequent health outcomes. It is critically important for clinicians to review the medication list with veterans screening positive for food insecurity to assess for risk of hypoglycemia and/or cost-related nonadherence, make any necessary adjustments to therapeutic regimens, and assess for additional risk factors associated with food insecurity. Examples of tailored nutrition counseling that clinical dietitians may provide include meal preparation strategies for veterans who only have access to a microwave or hotplate, or recommendations for how veterans on medically restricted diets can best navigate food selection at soup kitchens or food pantries. Resource referrals provided by social workers or other care team members may include both emergency food resources to address immediate shortages (eg, food pantries, soup kitchens, or vouchers for free lunch) as well as resources focused on improving longer term food security (eg, federal food assistance programs or home delivered meal programs). Importantly, although providing a list of food resources may be helpful for some patients, such lists are often insufficient.^62,63 Many patients require active assistance with program enrollment either onsite the day of their clinic visit or through connection with a partnering community-based organization that can, in turn, identify appropriate resources and facilitate program enrollment.^63,64 Planned follow-up is also crucial to determine whether referrals are successful and to assess for ongoing need. Proposed roles for interdisciplinary care team members in addressing a positive food insecurity screen are outlined in Table 1.

VHA-Community Partnerships

In addition to services offered within VA, public and private sector partnerships can greatly enhance the range of resources available to food insecure veterans. Several VA facilities have developed formal community partnerships, such as the Veterans Pantry Pilot (VPP) program, a national partnership between Feeding America food banks and VA medical centers to establish onsite or mobile food pantries. There are currently 17 active Feeding America VPP sites, with a number of additional sites under development. Several of the VPP sites also include other “wraparound services,” such as SNAP application assistance.^65,66

State Veterans Affairs offices⁶⁷ and Veterans Service Organizations (VSOs)⁶⁸ also can serve as valuable partners for connecting veterans with needed resources. VSOs offer a range of services, including assistancewith benefit claims, employment and housing assistance, emergency food assistance, and transportation to medical appointments. Some VSOs also have established local affiliations with Meals on Wheels focused on veteran outreach and providing hot meals for low-income, homebound, and disabled veterans.

Additional Resources

Although resources vary by regional setting, several key governmental and community-based food assistance programs are summarized in Table 2. Local community partners and online/phone-based directories, such as United Way’s 2-1-1 can help identify additional local resources. For older adults and individuals with disabilities, local Aging and Disability Resources Centers can provide information and assistance connecting to needed resources.⁶⁹ Finally, there are a number of online resources available for clinicians interested in learning more about the impact of food insecurity on health and tools to use in the clinical setting (Table 3).

Conclusion

The VA has recognized food insecurity as a critical concern for the well-being of our nation’s veterans. Use of the EHR clinical reminder represents a crucial first step toward increasing provider awareness about veteran food insecurity and improving clinical efforts to address food insecurity once identified. Through the reminder, health care teams can connect veterans to needed resources and create both the individual and population-level data necessary to inform VHA and community efforts to address veteran food insecurity. Clinical reminder data are currently being used for local quality improvement efforts and have established the need nationally for formalized partnerships between VHA Social Work Services and Nutrition and Food Services to connect veterans with food and provide them with strategies to best use available food resources.

Moving forward, the Ensuring Veteran Food Security Workgroup continues to work with agencies and organizations across the country to improve food insecure veterans’ access to needed services. In addition to existing VA partnerships with Feeding America for the VPP, memorandums of understanding are currently underway to formalize partnerships with both the Food Research and Action Center (FRAC) and MAZON. Additional research is needed both to formally validate the current food insecurity clinical reminder screening question and to identify best practices and potential models for how to most effectively use VHA-community partnerships to address the unique needs of the veteran population.

Ensuring the food security of our nation’s veterans is essential to VA’s commitment to providing integrated, veteran-centered, whole person care. Toward that goal, VA health care teams are urged to use the clinical reminder and help connect food insecure veterans with relevant resources both within and outside of the VA health care system.

Nearly 1 in 8 households—and 1 in 6 households with children—experienced food insecurity in 2017, defined as limited or uncertain availability of nutritionally adequate and safe foods.¹ Food insecurity is often even more pronounced among households with individuals with acute or chronic medical conditions.^2-6 Moreover, food insecurity is independently associated with a range of adverse health outcomes, including poorer control of diabetes mellitus, hypertension, depression and other major psychiatric disorders, HIV, and chronic lung and kidney disease, as well as poorer overall health status.^7-14 Food insecurity also has been associated with increased health care costs and acute care utilization as well as increased probability of delayed or missed care.^15-19

The relationship between food insecurity and poor health outcomes is a complex and often cyclic phenomenon (Figure 1). Poor nutritional status is fueled by limited access to healthful foods as well as increased reliance on calorie-dense and nutrient-poor “junk” foods, which are less expensive and often more readily available in low-income neighborhoods.^5,20-24 These compensatory dietary patterns place individuals at higher risk for developing cardiometabolic conditions and for poor control of these conditions.^{5,8,9,12,25,26} Additionally, the physiological and psychological stressors of food insecurity may precipitate depression and anxiety or worsen existing mental health conditions, resulting in feelings of overwhelm and decreased self-management capacity.^5,8,27-31 Food insecurity has further been associated with poor sleep, declines in cognitive function, and increased falls, particularly among the frail and elderly.^32-34

Prevalence and Importance of Food Insecurity Among US Veterans

Nearly 1.5 million veterans in the US are living below the federal poverty level (FPL).³⁹ An additional 2.4 million veterans are living paycheck to paycheck at < 200% of the FPL.⁴⁰ Veterans living in poverty are at even higher risk than nonveterans for food insecurity, homelessness, and other material hardship.⁴¹

Estimates of food insecurity among veterans vary widely, ranging from 6% to 24%—nearly twice that of the general US population.^8,42-45 Higher rates of food insecurity have been reported among certain high-risk subgroups, including veterans who served in Iraq and Afghanistan (27%), female veterans (28%), homeless and formerly homeless veterans (49%), and veterans with serious mental illness (35%).^6,32,43,46 Additional risk factors for food insecurity specific to veteran populations include younger age, having recently left active-duty military service, and lower final military paygrade.^42,45-47 As in the general population, veteran food insecurity is associated with a range of adverse health outcomes, including poorer overall health status as well as increased probability of delayed or missed care.^{6,8,32,42-44,46}

Even among veterans enrolled in federal food assistance programs, many still struggle to afford nutritionally adequate foods. As one example, in a study of mostly male homeless and formerly homeless veterans, O’Toole and colleagues found that nearly half of those reporting food insecurity were already receiving federal food assistance benefits, and 22% relied on emergency food resources.³² Of households served by Feeding America food pantries and meal programs, 20% have a member who has served in the US military.⁴⁸

Federal Programs To Address Food Insecurity

There are several important federal food assistance programs designed to help alleviate food insecurity. The Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp program) is the largest federal food assistance program and provides low-income Americans with cash benefits to purchase food. SNAP has been shown to substantially reduce food insecurity.^7,49 The program also is associated with significant decreases in cost-related medication nonadherence as well as reductions in health care costs and both acute care and nursing home utilization.^16,50-54 Although nearly 1.4 million veterans live in SNAP-enrolled households, 59% of eligible veterans are not enrolled.^43,55 Closing this SNAP eligibility-enrollment gap, has been a focus of recent efforts to improve long-term food security among veterans. There also are several federal food assistance programs for households with children, including the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and school meals programs. Among federal nutrition programs for seniors, the Older American’s Act contains designated funding to support nutrition services for older adults, including congregate meal programs in community settings like senior centers, places of worship, and housing communities, and home-delivered meals through programs like Meals on Wheels.⁵⁶

VHA Response to Food Insecurity

The Veterans Health Administration (VHA) is the country’s largest integrated, federally funded health care system.⁵⁷ In November 2015, congressional briefings on veteran food insecurity organized by the national non-profit organization MAZON: A Jewish Response to Hunger and hosted with bipartisan support were provided to the US House and Senate. As a result of these briefings, VHA chartered the national Ensuring Veteran Food Security Workgroup with a mandate to partner with governmental and nonprofit agencies to “focus on the issue of food insecurity, the identification of veterans at risk, the needed training of VHA staff and the coordination of resources and initiatives to support the veterans for whom we care.” Building off a pilot in US Department of Veterans Affairs (VA) Homeless Patient Aligned Care Teams (H-PACTs),³² VHA subsequently integrated a single-item food insecurity screening tool into the VA electronic health record (EHR) clinical reminder system (Figure 2). The clinical reminder, which was rolled out across VA medical centers nationally in October 2017, provides an alert to screen all noninstitutionalized veterans for food insecurity. To date, nearly 5 million veterans have been screened. When a veteran endorses food insecurity based on the initial screening question, a prompt appears to offer the veteran a referral to a social worker and/or dietitian. Positive screening results also should be communicated to the patient’s primary care provider. Depending on site-specific clinical flow, the reminders are typically completed in the outpatient setting either by nurses or medical assistants during intake or by providers as part of the clinical visit. However, any member of the health care team can complete the clinical reminder at any time. As of September 2019, approximately 74,000 veterans have been identified as food insecure.⁵⁸

Addressing Food Insecurity

VHA has been a recognized leader in addressing homelessness and other social determinants of health through its integrated care and PACT delivery models.^59-61 The food insecurity clinical reminder was designed to facilitate a tailored, interdisciplinary approach to identify and address food insecurity. Interdisciplinary care team members—including medical assistants, clinicians, social workers, registered dietitians, nurse care managers, occupational or physical therapists, and pharmacists—are uniquely positioned to identify veterans impacted by food insecurity, assess for associated clinical and/or social risk factors, and offer appropriate medical and nutrition interventions and resource referrals.

This interdisciplinary team-based model is essential given the range of potential drivers underlying veteran experiences of food insecurity and subsequent health outcomes. It is critically important for clinicians to review the medication list with veterans screening positive for food insecurity to assess for risk of hypoglycemia and/or cost-related nonadherence, make any necessary adjustments to therapeutic regimens, and assess for additional risk factors associated with food insecurity. Examples of tailored nutrition counseling that clinical dietitians may provide include meal preparation strategies for veterans who only have access to a microwave or hotplate, or recommendations for how veterans on medically restricted diets can best navigate food selection at soup kitchens or food pantries. Resource referrals provided by social workers or other care team members may include both emergency food resources to address immediate shortages (eg, food pantries, soup kitchens, or vouchers for free lunch) as well as resources focused on improving longer term food security (eg, federal food assistance programs or home delivered meal programs). Importantly, although providing a list of food resources may be helpful for some patients, such lists are often insufficient.^62,63 Many patients require active assistance with program enrollment either onsite the day of their clinic visit or through connection with a partnering community-based organization that can, in turn, identify appropriate resources and facilitate program enrollment.^63,64 Planned follow-up is also crucial to determine whether referrals are successful and to assess for ongoing need. Proposed roles for interdisciplinary care team members in addressing a positive food insecurity screen are outlined in Table 1.

VHA-Community Partnerships

In addition to services offered within VA, public and private sector partnerships can greatly enhance the range of resources available to food insecure veterans. Several VA facilities have developed formal community partnerships, such as the Veterans Pantry Pilot (VPP) program, a national partnership between Feeding America food banks and VA medical centers to establish onsite or mobile food pantries. There are currently 17 active Feeding America VPP sites, with a number of additional sites under development. Several of the VPP sites also include other “wraparound services,” such as SNAP application assistance.^65,66

State Veterans Affairs offices⁶⁷ and Veterans Service Organizations (VSOs)⁶⁸ also can serve as valuable partners for connecting veterans with needed resources. VSOs offer a range of services, including assistancewith benefit claims, employment and housing assistance, emergency food assistance, and transportation to medical appointments. Some VSOs also have established local affiliations with Meals on Wheels focused on veteran outreach and providing hot meals for low-income, homebound, and disabled veterans.

Additional Resources

Although resources vary by regional setting, several key governmental and community-based food assistance programs are summarized in Table 2. Local community partners and online/phone-based directories, such as United Way’s 2-1-1 can help identify additional local resources. For older adults and individuals with disabilities, local Aging and Disability Resources Centers can provide information and assistance connecting to needed resources.⁶⁹ Finally, there are a number of online resources available for clinicians interested in learning more about the impact of food insecurity on health and tools to use in the clinical setting (Table 3).

Conclusion

The VA has recognized food insecurity as a critical concern for the well-being of our nation’s veterans. Use of the EHR clinical reminder represents a crucial first step toward increasing provider awareness about veteran food insecurity and improving clinical efforts to address food insecurity once identified. Through the reminder, health care teams can connect veterans to needed resources and create both the individual and population-level data necessary to inform VHA and community efforts to address veteran food insecurity. Clinical reminder data are currently being used for local quality improvement efforts and have established the need nationally for formalized partnerships between VHA Social Work Services and Nutrition and Food Services to connect veterans with food and provide them with strategies to best use available food resources.

Moving forward, the Ensuring Veteran Food Security Workgroup continues to work with agencies and organizations across the country to improve food insecure veterans’ access to needed services. In addition to existing VA partnerships with Feeding America for the VPP, memorandums of understanding are currently underway to formalize partnerships with both the Food Research and Action Center (FRAC) and MAZON. Additional research is needed both to formally validate the current food insecurity clinical reminder screening question and to identify best practices and potential models for how to most effectively use VHA-community partnerships to address the unique needs of the veteran population.

Ensuring the food security of our nation’s veterans is essential to VA’s commitment to providing integrated, veteran-centered, whole person care. Toward that goal, VA health care teams are urged to use the clinical reminder and help connect food insecure veterans with relevant resources both within and outside of the VA health care system.

Nearly 1 in 8 households—and 1 in 6 households with children—experienced food insecurity in 2017, defined as limited or uncertain availability of nutritionally adequate and safe foods.¹ Food insecurity is often even more pronounced among households with individuals with acute or chronic medical conditions.^2-6 Moreover, food insecurity is independently associated with a range of adverse health outcomes, including poorer control of diabetes mellitus, hypertension, depression and other major psychiatric disorders, HIV, and chronic lung and kidney disease, as well as poorer overall health status.^7-14 Food insecurity also has been associated with increased health care costs and acute care utilization as well as increased probability of delayed or missed care.^15-19

The relationship between food insecurity and poor health outcomes is a complex and often cyclic phenomenon (Figure 1). Poor nutritional status is fueled by limited access to healthful foods as well as increased reliance on calorie-dense and nutrient-poor “junk” foods, which are less expensive and often more readily available in low-income neighborhoods.^5,20-24 These compensatory dietary patterns place individuals at higher risk for developing cardiometabolic conditions and for poor control of these conditions.^{5,8,9,12,25,26} Additionally, the physiological and psychological stressors of food insecurity may precipitate depression and anxiety or worsen existing mental health conditions, resulting in feelings of overwhelm and decreased self-management capacity.^5,8,27-31 Food insecurity has further been associated with poor sleep, declines in cognitive function, and increased falls, particularly among the frail and elderly.^32-34

Prevalence and Importance of Food Insecurity Among US Veterans

Nearly 1.5 million veterans in the US are living below the federal poverty level (FPL).³⁹ An additional 2.4 million veterans are living paycheck to paycheck at < 200% of the FPL.⁴⁰ Veterans living in poverty are at even higher risk than nonveterans for food insecurity, homelessness, and other material hardship.⁴¹

Estimates of food insecurity among veterans vary widely, ranging from 6% to 24%—nearly twice that of the general US population.^8,42-45 Higher rates of food insecurity have been reported among certain high-risk subgroups, including veterans who served in Iraq and Afghanistan (27%), female veterans (28%), homeless and formerly homeless veterans (49%), and veterans with serious mental illness (35%).^6,32,43,46 Additional risk factors for food insecurity specific to veteran populations include younger age, having recently left active-duty military service, and lower final military paygrade.^42,45-47 As in the general population, veteran food insecurity is associated with a range of adverse health outcomes, including poorer overall health status as well as increased probability of delayed or missed care.^{6,8,32,42-44,46}

Even among veterans enrolled in federal food assistance programs, many still struggle to afford nutritionally adequate foods. As one example, in a study of mostly male homeless and formerly homeless veterans, O’Toole and colleagues found that nearly half of those reporting food insecurity were already receiving federal food assistance benefits, and 22% relied on emergency food resources.³² Of households served by Feeding America food pantries and meal programs, 20% have a member who has served in the US military.⁴⁸

Federal Programs To Address Food Insecurity

There are several important federal food assistance programs designed to help alleviate food insecurity. The Supplemental Nutrition Assistance Program (SNAP, formerly the Food Stamp program) is the largest federal food assistance program and provides low-income Americans with cash benefits to purchase food. SNAP has been shown to substantially reduce food insecurity.^7,49 The program also is associated with significant decreases in cost-related medication nonadherence as well as reductions in health care costs and both acute care and nursing home utilization.^16,50-54 Although nearly 1.4 million veterans live in SNAP-enrolled households, 59% of eligible veterans are not enrolled.^43,55 Closing this SNAP eligibility-enrollment gap, has been a focus of recent efforts to improve long-term food security among veterans. There also are several federal food assistance programs for households with children, including the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) and school meals programs. Among federal nutrition programs for seniors, the Older American’s Act contains designated funding to support nutrition services for older adults, including congregate meal programs in community settings like senior centers, places of worship, and housing communities, and home-delivered meals through programs like Meals on Wheels.⁵⁶

VHA Response to Food Insecurity

The Veterans Health Administration (VHA) is the country’s largest integrated, federally funded health care system.⁵⁷ In November 2015, congressional briefings on veteran food insecurity organized by the national non-profit organization MAZON: A Jewish Response to Hunger and hosted with bipartisan support were provided to the US House and Senate. As a result of these briefings, VHA chartered the national Ensuring Veteran Food Security Workgroup with a mandate to partner with governmental and nonprofit agencies to “focus on the issue of food insecurity, the identification of veterans at risk, the needed training of VHA staff and the coordination of resources and initiatives to support the veterans for whom we care.” Building off a pilot in US Department of Veterans Affairs (VA) Homeless Patient Aligned Care Teams (H-PACTs),³² VHA subsequently integrated a single-item food insecurity screening tool into the VA electronic health record (EHR) clinical reminder system (Figure 2). The clinical reminder, which was rolled out across VA medical centers nationally in October 2017, provides an alert to screen all noninstitutionalized veterans for food insecurity. To date, nearly 5 million veterans have been screened. When a veteran endorses food insecurity based on the initial screening question, a prompt appears to offer the veteran a referral to a social worker and/or dietitian. Positive screening results also should be communicated to the patient’s primary care provider. Depending on site-specific clinical flow, the reminders are typically completed in the outpatient setting either by nurses or medical assistants during intake or by providers as part of the clinical visit. However, any member of the health care team can complete the clinical reminder at any time. As of September 2019, approximately 74,000 veterans have been identified as food insecure.⁵⁸

Addressing Food Insecurity

VHA has been a recognized leader in addressing homelessness and other social determinants of health through its integrated care and PACT delivery models.^59-61 The food insecurity clinical reminder was designed to facilitate a tailored, interdisciplinary approach to identify and address food insecurity. Interdisciplinary care team members—including medical assistants, clinicians, social workers, registered dietitians, nurse care managers, occupational or physical therapists, and pharmacists—are uniquely positioned to identify veterans impacted by food insecurity, assess for associated clinical and/or social risk factors, and offer appropriate medical and nutrition interventions and resource referrals.

This interdisciplinary team-based model is essential given the range of potential drivers underlying veteran experiences of food insecurity and subsequent health outcomes. It is critically important for clinicians to review the medication list with veterans screening positive for food insecurity to assess for risk of hypoglycemia and/or cost-related nonadherence, make any necessary adjustments to therapeutic regimens, and assess for additional risk factors associated with food insecurity. Examples of tailored nutrition counseling that clinical dietitians may provide include meal preparation strategies for veterans who only have access to a microwave or hotplate, or recommendations for how veterans on medically restricted diets can best navigate food selection at soup kitchens or food pantries. Resource referrals provided by social workers or other care team members may include both emergency food resources to address immediate shortages (eg, food pantries, soup kitchens, or vouchers for free lunch) as well as resources focused on improving longer term food security (eg, federal food assistance programs or home delivered meal programs). Importantly, although providing a list of food resources may be helpful for some patients, such lists are often insufficient.^62,63 Many patients require active assistance with program enrollment either onsite the day of their clinic visit or through connection with a partnering community-based organization that can, in turn, identify appropriate resources and facilitate program enrollment.^63,64 Planned follow-up is also crucial to determine whether referrals are successful and to assess for ongoing need. Proposed roles for interdisciplinary care team members in addressing a positive food insecurity screen are outlined in Table 1.

VHA-Community Partnerships

In addition to services offered within VA, public and private sector partnerships can greatly enhance the range of resources available to food insecure veterans. Several VA facilities have developed formal community partnerships, such as the Veterans Pantry Pilot (VPP) program, a national partnership between Feeding America food banks and VA medical centers to establish onsite or mobile food pantries. There are currently 17 active Feeding America VPP sites, with a number of additional sites under development. Several of the VPP sites also include other “wraparound services,” such as SNAP application assistance.^65,66

State Veterans Affairs offices⁶⁷ and Veterans Service Organizations (VSOs)⁶⁸ also can serve as valuable partners for connecting veterans with needed resources. VSOs offer a range of services, including assistancewith benefit claims, employment and housing assistance, emergency food assistance, and transportation to medical appointments. Some VSOs also have established local affiliations with Meals on Wheels focused on veteran outreach and providing hot meals for low-income, homebound, and disabled veterans.

Additional Resources

Although resources vary by regional setting, several key governmental and community-based food assistance programs are summarized in Table 2. Local community partners and online/phone-based directories, such as United Way’s 2-1-1 can help identify additional local resources. For older adults and individuals with disabilities, local Aging and Disability Resources Centers can provide information and assistance connecting to needed resources.⁶⁹ Finally, there are a number of online resources available for clinicians interested in learning more about the impact of food insecurity on health and tools to use in the clinical setting (Table 3).

Conclusion

The VA has recognized food insecurity as a critical concern for the well-being of our nation’s veterans. Use of the EHR clinical reminder represents a crucial first step toward increasing provider awareness about veteran food insecurity and improving clinical efforts to address food insecurity once identified. Through the reminder, health care teams can connect veterans to needed resources and create both the individual and population-level data necessary to inform VHA and community efforts to address veteran food insecurity. Clinical reminder data are currently being used for local quality improvement efforts and have established the need nationally for formalized partnerships between VHA Social Work Services and Nutrition and Food Services to connect veterans with food and provide them with strategies to best use available food resources.

Moving forward, the Ensuring Veteran Food Security Workgroup continues to work with agencies and organizations across the country to improve food insecure veterans’ access to needed services. In addition to existing VA partnerships with Feeding America for the VPP, memorandums of understanding are currently underway to formalize partnerships with both the Food Research and Action Center (FRAC) and MAZON. Additional research is needed both to formally validate the current food insecurity clinical reminder screening question and to identify best practices and potential models for how to most effectively use VHA-community partnerships to address the unique needs of the veteran population.

Ensuring the food security of our nation’s veterans is essential to VA’s commitment to providing integrated, veteran-centered, whole person care. Toward that goal, VA health care teams are urged to use the clinical reminder and help connect food insecure veterans with relevant resources both within and outside of the VA health care system.

The certainty that federal health care will be different, and the equal uncertainty about when and how the systems will evolve, were major topics at the recent AMSUS annual meeting. The Veterans Health Administration (VHA) and Military Health System (MHS) are in the midst of major transformations, although they are at very different points in the process and the final outcomes are yet unknown. This editorial, written at the end of 2019, will review some of the highlights of a discussion that is sure to continue in 2020 and beyond.

Almost everyone in the VA and many of the public can pinpoint the exact place (and time) the VHA’s upheaval began: Phoenix, Arizona, in 2014. “The attack on our system,” as VHA Executive in Charge Richard A. Stone, MD, described it at AMSUS, happened because “we were just too slow a bureaucracy,” he explained.¹ “We can debate how many veterans died while waiting for care, but the answer is that 1 was too many and it had to be fixed. We had to become a more agile organization.”

The US Department of Veterans Affairs (VA) response to the media firestorm and congressional outrage was uncharacteristically swift and sweeping. Both the VA Secretary and Deputy Under Secretary of Health were removed, as were many others in leadership at Phoenix and elsewhere. The VA faced an existential crisis as many loud voices called for dismantling the entire system in the wake of its perceived inability or unwillingness to care for those it was legally mandated to serve.² The Veterans’ Access to Care through Choice, Accountability, and Transparency Act of 2014 and its successor the VA Mission Act of 2018 dramatically expanded veterans’ access to covered health care from non-VA health care providers (HCPs).

Debate continues in the veteran community and the wider society about whether this expansion constitutes an abandonment of a health care system dedicated to veterans and their unique health problems or a commitment to deliver the most efficient and high-quality care to veterans that can be obtained.^3-5 Many see this as a crossroads for the VA. Still, even if the VA will continue to exist, the question remains: in what form?

The increased use of private sector HCPs has wrought significant and long-lasting modifications to the traditional VA organization. In fiscal year (FY) 2017, the VA paid for care that non-VA HCPs provided for 24% of patients.⁶ Veterans with higher service-connected disability ratings and aged > 65 years were more likely to rely on the VA for care than were less disabled and younger patients.⁶ The Mission Act is expected to increase the VA expenditures by nearly $19 billion between FY 2019 and FY 2023, with the bulk of the patients still going to the VHA for their care.⁶ Stakeholders from unions to politicians are concerned that every dollar spent on community care is one less they can spend in VA institutions. It is unclear to what degree this concern will be actualized, as smaller hospitals and those in rural areas have always had contact with the private sector to obtain the specialty care veterans needed that the VA could not provide.

Compounding these trends is the VA’s ongoing staffing challenges. To meet the demand and eliminate wait times between September 2014 and September 2018, the VHA grew its workforce by > 40,000 individuals, a 13% growth rate. In FY 2019 alone, the VHA hired 28,000 new employees. And yet despite the rapid growth, a lower than average turnover rate, and relatively high employee satisfaction measures (at least when compared with those of other federal employees), the VHA still has 43,000 vacancies.^7,8

Which brings us to the very different set of challenges facing the Defense Health Agency (DHA). In an era of ballooning military budgets the DHA is being asked to “transform the MHS into an integrated readiness and health system, eliminate redundancies, and create a common high-quality experience for our beneficiaries.”⁹ The seeds of change were tucked into the National Defense Authorization Act (NDAA) of 2017, and their ramifications are only now becoming apparent. Among the most consequential of these changes are transfer of the management of hundreds of MHS hospitals and clinics from the medical services of the Army, Navy, and Air Force to the DHA.

“If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs explained at AMSUS.¹⁰ In October 2019, DoD transitioned the first group of facilities to the DHA, and the remainder will change management by the end of 2022. In the next step of the process, facilities will be combined—along with TRICARE providers—in 21 geographically based “markets” to streamline management and avoid “redundancies.” 

Lost in the bland language, though, is the scale of the contemplated changes. Although the exact shape of the changes have not been finalized, up to 18,000 MHS health care providers—civilian or uniformed—may be eliminated as DHA relies more heavily on TRICARE providers.¹¹ Not even the future of the Uniformed Service University for the Health Sciences and its leadership training and health care research are guaranteed.¹² The ominous possibility that the nation could lose its only military medical school has raised alarm among medical educators. They fear that the country may sacrifice its ability to train physicians with the highly skilled specialities needed on the battlefield and the familiarity with military culture that enables doctors in uniform to relate to the problems of active-duty families and retired service members.¹²VHA and MHS colleagues are undergoing a similar organizational transition with all the trepidation and expectation that accompanies the turning of an enormous ship in stormy seas. In the midst of these major institutional transformations, VHA and MHS need to band together if the unique specialty of military and VA medicine is to survive. Unless these unprecedented changes can establish a new spirit of solidarity to 2 often separate partners in one mission to care for those who serve, we may well be asking in the next few years, “Where have all the federal practitioners gone?”

The certainty that federal health care will be different, and the equal uncertainty about when and how the systems will evolve, were major topics at the recent AMSUS annual meeting. The Veterans Health Administration (VHA) and Military Health System (MHS) are in the midst of major transformations, although they are at very different points in the process and the final outcomes are yet unknown. This editorial, written at the end of 2019, will review some of the highlights of a discussion that is sure to continue in 2020 and beyond.

Almost everyone in the VA and many of the public can pinpoint the exact place (and time) the VHA’s upheaval began: Phoenix, Arizona, in 2014. “The attack on our system,” as VHA Executive in Charge Richard A. Stone, MD, described it at AMSUS, happened because “we were just too slow a bureaucracy,” he explained.¹ “We can debate how many veterans died while waiting for care, but the answer is that 1 was too many and it had to be fixed. We had to become a more agile organization.”

The US Department of Veterans Affairs (VA) response to the media firestorm and congressional outrage was uncharacteristically swift and sweeping. Both the VA Secretary and Deputy Under Secretary of Health were removed, as were many others in leadership at Phoenix and elsewhere. The VA faced an existential crisis as many loud voices called for dismantling the entire system in the wake of its perceived inability or unwillingness to care for those it was legally mandated to serve.² The Veterans’ Access to Care through Choice, Accountability, and Transparency Act of 2014 and its successor the VA Mission Act of 2018 dramatically expanded veterans’ access to covered health care from non-VA health care providers (HCPs).

Debate continues in the veteran community and the wider society about whether this expansion constitutes an abandonment of a health care system dedicated to veterans and their unique health problems or a commitment to deliver the most efficient and high-quality care to veterans that can be obtained.^3-5 Many see this as a crossroads for the VA. Still, even if the VA will continue to exist, the question remains: in what form?

The increased use of private sector HCPs has wrought significant and long-lasting modifications to the traditional VA organization. In fiscal year (FY) 2017, the VA paid for care that non-VA HCPs provided for 24% of patients.⁶ Veterans with higher service-connected disability ratings and aged > 65 years were more likely to rely on the VA for care than were less disabled and younger patients.⁶ The Mission Act is expected to increase the VA expenditures by nearly $19 billion between FY 2019 and FY 2023, with the bulk of the patients still going to the VHA for their care.⁶ Stakeholders from unions to politicians are concerned that every dollar spent on community care is one less they can spend in VA institutions. It is unclear to what degree this concern will be actualized, as smaller hospitals and those in rural areas have always had contact with the private sector to obtain the specialty care veterans needed that the VA could not provide.

Compounding these trends is the VA’s ongoing staffing challenges. To meet the demand and eliminate wait times between September 2014 and September 2018, the VHA grew its workforce by > 40,000 individuals, a 13% growth rate. In FY 2019 alone, the VHA hired 28,000 new employees. And yet despite the rapid growth, a lower than average turnover rate, and relatively high employee satisfaction measures (at least when compared with those of other federal employees), the VHA still has 43,000 vacancies.^7,8

Which brings us to the very different set of challenges facing the Defense Health Agency (DHA). In an era of ballooning military budgets the DHA is being asked to “transform the MHS into an integrated readiness and health system, eliminate redundancies, and create a common high-quality experience for our beneficiaries.”⁹ The seeds of change were tucked into the National Defense Authorization Act (NDAA) of 2017, and their ramifications are only now becoming apparent. Among the most consequential of these changes are transfer of the management of hundreds of MHS hospitals and clinics from the medical services of the Army, Navy, and Air Force to the DHA.

“If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs explained at AMSUS.¹⁰ In October 2019, DoD transitioned the first group of facilities to the DHA, and the remainder will change management by the end of 2022. In the next step of the process, facilities will be combined—along with TRICARE providers—in 21 geographically based “markets” to streamline management and avoid “redundancies.” 

Lost in the bland language, though, is the scale of the contemplated changes. Although the exact shape of the changes have not been finalized, up to 18,000 MHS health care providers—civilian or uniformed—may be eliminated as DHA relies more heavily on TRICARE providers.¹¹ Not even the future of the Uniformed Service University for the Health Sciences and its leadership training and health care research are guaranteed.¹² The ominous possibility that the nation could lose its only military medical school has raised alarm among medical educators. They fear that the country may sacrifice its ability to train physicians with the highly skilled specialities needed on the battlefield and the familiarity with military culture that enables doctors in uniform to relate to the problems of active-duty families and retired service members.¹²VHA and MHS colleagues are undergoing a similar organizational transition with all the trepidation and expectation that accompanies the turning of an enormous ship in stormy seas. In the midst of these major institutional transformations, VHA and MHS need to band together if the unique specialty of military and VA medicine is to survive. Unless these unprecedented changes can establish a new spirit of solidarity to 2 often separate partners in one mission to care for those who serve, we may well be asking in the next few years, “Where have all the federal practitioners gone?”

The certainty that federal health care will be different, and the equal uncertainty about when and how the systems will evolve, were major topics at the recent AMSUS annual meeting. The Veterans Health Administration (VHA) and Military Health System (MHS) are in the midst of major transformations, although they are at very different points in the process and the final outcomes are yet unknown. This editorial, written at the end of 2019, will review some of the highlights of a discussion that is sure to continue in 2020 and beyond.

Almost everyone in the VA and many of the public can pinpoint the exact place (and time) the VHA’s upheaval began: Phoenix, Arizona, in 2014. “The attack on our system,” as VHA Executive in Charge Richard A. Stone, MD, described it at AMSUS, happened because “we were just too slow a bureaucracy,” he explained.¹ “We can debate how many veterans died while waiting for care, but the answer is that 1 was too many and it had to be fixed. We had to become a more agile organization.”

The US Department of Veterans Affairs (VA) response to the media firestorm and congressional outrage was uncharacteristically swift and sweeping. Both the VA Secretary and Deputy Under Secretary of Health were removed, as were many others in leadership at Phoenix and elsewhere. The VA faced an existential crisis as many loud voices called for dismantling the entire system in the wake of its perceived inability or unwillingness to care for those it was legally mandated to serve.² The Veterans’ Access to Care through Choice, Accountability, and Transparency Act of 2014 and its successor the VA Mission Act of 2018 dramatically expanded veterans’ access to covered health care from non-VA health care providers (HCPs).

Debate continues in the veteran community and the wider society about whether this expansion constitutes an abandonment of a health care system dedicated to veterans and their unique health problems or a commitment to deliver the most efficient and high-quality care to veterans that can be obtained.^3-5 Many see this as a crossroads for the VA. Still, even if the VA will continue to exist, the question remains: in what form?

The increased use of private sector HCPs has wrought significant and long-lasting modifications to the traditional VA organization. In fiscal year (FY) 2017, the VA paid for care that non-VA HCPs provided for 24% of patients.⁶ Veterans with higher service-connected disability ratings and aged > 65 years were more likely to rely on the VA for care than were less disabled and younger patients.⁶ The Mission Act is expected to increase the VA expenditures by nearly $19 billion between FY 2019 and FY 2023, with the bulk of the patients still going to the VHA for their care.⁶ Stakeholders from unions to politicians are concerned that every dollar spent on community care is one less they can spend in VA institutions. It is unclear to what degree this concern will be actualized, as smaller hospitals and those in rural areas have always had contact with the private sector to obtain the specialty care veterans needed that the VA could not provide.

Compounding these trends is the VA’s ongoing staffing challenges. To meet the demand and eliminate wait times between September 2014 and September 2018, the VHA grew its workforce by > 40,000 individuals, a 13% growth rate. In FY 2019 alone, the VHA hired 28,000 new employees. And yet despite the rapid growth, a lower than average turnover rate, and relatively high employee satisfaction measures (at least when compared with those of other federal employees), the VHA still has 43,000 vacancies.^7,8

Which brings us to the very different set of challenges facing the Defense Health Agency (DHA). In an era of ballooning military budgets the DHA is being asked to “transform the MHS into an integrated readiness and health system, eliminate redundancies, and create a common high-quality experience for our beneficiaries.”⁹ The seeds of change were tucked into the National Defense Authorization Act (NDAA) of 2017, and their ramifications are only now becoming apparent. Among the most consequential of these changes are transfer of the management of hundreds of MHS hospitals and clinics from the medical services of the Army, Navy, and Air Force to the DHA.

“If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs explained at AMSUS.¹⁰ In October 2019, DoD transitioned the first group of facilities to the DHA, and the remainder will change management by the end of 2022. In the next step of the process, facilities will be combined—along with TRICARE providers—in 21 geographically based “markets” to streamline management and avoid “redundancies.” 

Lost in the bland language, though, is the scale of the contemplated changes. Although the exact shape of the changes have not been finalized, up to 18,000 MHS health care providers—civilian or uniformed—may be eliminated as DHA relies more heavily on TRICARE providers.¹¹ Not even the future of the Uniformed Service University for the Health Sciences and its leadership training and health care research are guaranteed.¹² The ominous possibility that the nation could lose its only military medical school has raised alarm among medical educators. They fear that the country may sacrifice its ability to train physicians with the highly skilled specialities needed on the battlefield and the familiarity with military culture that enables doctors in uniform to relate to the problems of active-duty families and retired service members.¹²VHA and MHS colleagues are undergoing a similar organizational transition with all the trepidation and expectation that accompanies the turning of an enormous ship in stormy seas. In the midst of these major institutional transformations, VHA and MHS need to band together if the unique specialty of military and VA medicine is to survive. Unless these unprecedented changes can establish a new spirit of solidarity to 2 often separate partners in one mission to care for those who serve, we may well be asking in the next few years, “Where have all the federal practitioners gone?”

The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.

Wikimedia Commons/WWsgConnect/CC-SA 4.0

HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.

“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”

The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.

He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”

The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.

Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.

Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.

Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.

States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.

Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”

The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.

The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.

“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.

Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.

The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.

“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.

The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.

“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.

[email protected]

The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.

Wikimedia Commons/WWsgConnect/CC-SA 4.0

HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.

“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”

The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.

He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”

The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.

Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.

Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.

Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.

States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.

Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”

The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.

The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.

“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.

Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.

The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.

“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.

The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.

“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.

[email protected]

The Department of Health & Human Services is taking the first steps in allowing drugs to be imported into the United States.

Wikimedia Commons/WWsgConnect/CC-SA 4.0

HHS proposes to offer two different pathways for importation: One allowing states to design programs to import certain drugs directly from Canada and another allowing manufacturers to obtain a new National Drug Code (NDC) number to import their own Food and Drug Administration–approved products manufactured outside of the United States.

“The importation proposals we are rolling out ... are a historic step forward in efforts to bring down drug prices and out-of-pocket costs,” HHS Secretary Alex Azar said during a Dec. 17, 2019, press conference. “New pathways for importation can move us toward a more open and competitive marketplace that supplies American patients with safe, effective, affordable prescription drugs.”

The proposals were made public on Dec. 18, the day the House Rules committee was scheduled to vote on impeaching President Trump.

He emphasized that these proposals “are both important steps in advancing the FDA’s safe-importation action plan, [which] aims to insure that importation is done in a way that prioritizes safety and includes elements to help insure importation does not put patients or the U.S. drug supply chain at risk.”

The pathway for states to import drugs from Canada will be proposed through the federal regulatory process. The notice of proposed rulemaking, which implements authority for FDA regulation of importation granted in the Medicare Modernization Act of 2003, will outline a process by which states, potentially working with wholesalers and/or pharmacies, will submit proposals for FDA review and approval on how they would implement an importation program.

Only certain drugs would be eligible for importation from Canada under this proposal. The drugs would need to be approved in Canada and, except for Canadian labeling, need to meet the conditions of an FDA-approved new drug application or abbreviated new drug application.

Controlled substances, biologics, intravenously injected drugs, drugs with a risk evaluation and management strategy, and drugs injected into the spinal column or eye would be excluded from importation.

Drugs coming in from Canada would be relabeled with U.S.-approved labels and would be subject to testing to ensure they are authentic, not degraded, and compliant with U.S. standards.

States would be required to show that importing drugs poses no additional risk in public health and safety and it would result in the reduction of costs, according to information provided by HHS.

Many of the most expensive drugs, as well as insulins, would not be eligible for importation under this pathway, Mr. Azar acknowledged, adding that “I would envision that as we demonstrate the safety as well as the cost savings from this pathway, [this could serve as] a pilot and a proof of concept that Congress could then look to and potentially take up for more complex molecules that involve cold-chain storage and more complex distribution channels.”

The proposed regulations do not offer any estimates on how much savings could be achieved. He said that there is no way to estimate which states might develop importation plans and how those plans might work.

The second proposed pathway would involve FDA guidance to manufacturers allowing them to import their own FDA-approved products manufactured abroad. Under this proposal, there would be no restriction on which type or kind of FDA-approved product to be imported.

“The FDA has become aware that manufacturers of some brand-name drugs want to offer their drugs at lower costs in the U.S. market but, due to certain challenges in the private market, are not readily [able] to do so without obtaining a different national drug code for their drugs,” Adm. Brett Giroir, MD, HHS assistant secretary for health, said during the press conference.

Obtaining a separate NDC for imported drugs could address the challenges, particularly those posed by the incentives to raise list prices and offer higher rebates to pharmacy benefit managers, Mr. Azar said.

The draft guidance outlines procedures manufacturers could follow to get that NDC for those products and how manufacturers can demonstrate that these products meet U.S. regulatory standards. Products imported in this pathway could be made available to patients in hospitals, physician offices, and pharmacies. Generic drugs are not part of this guidance, but the proposed guidance asked for feedback on whether a similar approach is needed for generic products.

“This would potentially allow for the sale of these drugs at lower prices than currently offered to American consumers, giving drugmakers new flexibility to reduce list prices,” Mr. Azar said.

The proposed regulation on state-level importation will have a 75-day comment period from the day it is published in the Federal Register, and Mr. Azar said that the FDA is committing resources to getting the comments analyzed and reflected in the final rule.

“We will be moving as quickly as we possibly can,” Mr. Azar said, adding that the FDA guidance to manufacturers may move more quickly through its approval process because it is not a formal rule.

[email protected]

More work is needed to address how addiction is handled both within the military and for veterans after they serve. Removing the stigma around addiction treatment is key to addressing the issue, Anthony Dekker, DO, Northern Arizona VA Healthcare System, said at the AMSUS annual meeting on December 4, 2019.

“When we are talking about treating addiction in the military and the VA, those are 2 different issues,” Dr. Dekker said. “In the VA, it should be understood this is a service that needs to be provided. In the military, it is highly dependent on command. Some commands are in favor of treatment. Some commands are in favor of separation.”

But that separation comes with a cost. Dr. Dekker noted that the military spends about $200,000 to get a person from recruitment to an E-5 pay grade and about $400,000 to an O-5 pay grade. That can be a huge investment loss considering the cost of treatment for someone who is suffering from a use disorder.

“Treatment is going to cost about $44,000,” he said. “That will be treatment in a residential center. That was a person who is serious enough to come into a residential center, follow up with a partial hospital program and continue with ongoing [treatment] that would last a year.”

He touted some of the successes addiction treatment programs have had, recalling data from 2008-2009 from 110 military active-duty service members treated across 5 residential treatment centers in the Washington, DC, area. Within a year, 91% had separated from the military either because of a command decision before treatment or because of loss of recover.

“We know what works in addiction,” he said, noting that program changes that involved using a combination of medication-assisted treatments with regular substance use screenings and medical practitioner follow-up has helped to reduce the rate of lost recovery to 12%. He also noted that in 2013-2014, 41 active military members who received treatment in the same centers were able to be redeployed to Afghanistan and had no relapses during that deployment. 

“We try to take the stigma away,” Dr. Dekker said. “So if you have leadership who has a stigma against addiction treatment, you are going to have a steep incline to work against, whereas if you have leadership that were, I would say, endowed with a different sense of knowledge and experience,” there is a much greater chance for helping both military service members and veterans alike.

He called on the US Department of Veterans Affairs (VA) to look more closely at how it is prescribing opioids. While acknowledging the opioid addiction epidemic, he noted that simply cutting back on prescribing may not be the right solution because it is having a ripple effect and causing other problems, namely that although the VA has written 60% fewer opioid prescriptions from 2012 to 2019, overdose rates have doubled as military members and veterans are seeking opioids from other sources outside of a controlled, safer medical environment.

It can be especially problematic for those who have a legitimate medical need for opioids but have a disqualifying event that causes the pain medication to be cut off.

“We need to have a different answer to this because termination of opioids because a patient is positive for marijuana or even positive for cocaine doesn’t mean you take services away. You ramp services up,” Dr. Dekker said. “If I have a patient who has a chronic pain syndrome, the only thing that is going to push him out of my system is if they threaten my staff.…The loss from recovery is not a reason to lose treatment. That is another concept that needs to be addressed and we need to really look at that.”

He also called on VA leadership to be more encouraging in prescribing buprenorphine, noting that many doctors and nurses have waivers to prescribe it, but there is a lot of reluctance to do so, even though there is a lot of success with that treatment.

More work is needed to address how addiction is handled both within the military and for veterans after they serve. Removing the stigma around addiction treatment is key to addressing the issue, Anthony Dekker, DO, Northern Arizona VA Healthcare System, said at the AMSUS annual meeting on December 4, 2019.

“When we are talking about treating addiction in the military and the VA, those are 2 different issues,” Dr. Dekker said. “In the VA, it should be understood this is a service that needs to be provided. In the military, it is highly dependent on command. Some commands are in favor of treatment. Some commands are in favor of separation.”

But that separation comes with a cost. Dr. Dekker noted that the military spends about $200,000 to get a person from recruitment to an E-5 pay grade and about $400,000 to an O-5 pay grade. That can be a huge investment loss considering the cost of treatment for someone who is suffering from a use disorder.

“Treatment is going to cost about $44,000,” he said. “That will be treatment in a residential center. That was a person who is serious enough to come into a residential center, follow up with a partial hospital program and continue with ongoing [treatment] that would last a year.”

He touted some of the successes addiction treatment programs have had, recalling data from 2008-2009 from 110 military active-duty service members treated across 5 residential treatment centers in the Washington, DC, area. Within a year, 91% had separated from the military either because of a command decision before treatment or because of loss of recover.

“We know what works in addiction,” he said, noting that program changes that involved using a combination of medication-assisted treatments with regular substance use screenings and medical practitioner follow-up has helped to reduce the rate of lost recovery to 12%. He also noted that in 2013-2014, 41 active military members who received treatment in the same centers were able to be redeployed to Afghanistan and had no relapses during that deployment. 

“We try to take the stigma away,” Dr. Dekker said. “So if you have leadership who has a stigma against addiction treatment, you are going to have a steep incline to work against, whereas if you have leadership that were, I would say, endowed with a different sense of knowledge and experience,” there is a much greater chance for helping both military service members and veterans alike.

He called on the US Department of Veterans Affairs (VA) to look more closely at how it is prescribing opioids. While acknowledging the opioid addiction epidemic, he noted that simply cutting back on prescribing may not be the right solution because it is having a ripple effect and causing other problems, namely that although the VA has written 60% fewer opioid prescriptions from 2012 to 2019, overdose rates have doubled as military members and veterans are seeking opioids from other sources outside of a controlled, safer medical environment.

It can be especially problematic for those who have a legitimate medical need for opioids but have a disqualifying event that causes the pain medication to be cut off.

“We need to have a different answer to this because termination of opioids because a patient is positive for marijuana or even positive for cocaine doesn’t mean you take services away. You ramp services up,” Dr. Dekker said. “If I have a patient who has a chronic pain syndrome, the only thing that is going to push him out of my system is if they threaten my staff.…The loss from recovery is not a reason to lose treatment. That is another concept that needs to be addressed and we need to really look at that.”

He also called on VA leadership to be more encouraging in prescribing buprenorphine, noting that many doctors and nurses have waivers to prescribe it, but there is a lot of reluctance to do so, even though there is a lot of success with that treatment.

More work is needed to address how addiction is handled both within the military and for veterans after they serve. Removing the stigma around addiction treatment is key to addressing the issue, Anthony Dekker, DO, Northern Arizona VA Healthcare System, said at the AMSUS annual meeting on December 4, 2019.

“When we are talking about treating addiction in the military and the VA, those are 2 different issues,” Dr. Dekker said. “In the VA, it should be understood this is a service that needs to be provided. In the military, it is highly dependent on command. Some commands are in favor of treatment. Some commands are in favor of separation.”

But that separation comes with a cost. Dr. Dekker noted that the military spends about $200,000 to get a person from recruitment to an E-5 pay grade and about $400,000 to an O-5 pay grade. That can be a huge investment loss considering the cost of treatment for someone who is suffering from a use disorder.

“Treatment is going to cost about $44,000,” he said. “That will be treatment in a residential center. That was a person who is serious enough to come into a residential center, follow up with a partial hospital program and continue with ongoing [treatment] that would last a year.”

He touted some of the successes addiction treatment programs have had, recalling data from 2008-2009 from 110 military active-duty service members treated across 5 residential treatment centers in the Washington, DC, area. Within a year, 91% had separated from the military either because of a command decision before treatment or because of loss of recover.

“We know what works in addiction,” he said, noting that program changes that involved using a combination of medication-assisted treatments with regular substance use screenings and medical practitioner follow-up has helped to reduce the rate of lost recovery to 12%. He also noted that in 2013-2014, 41 active military members who received treatment in the same centers were able to be redeployed to Afghanistan and had no relapses during that deployment. 

“We try to take the stigma away,” Dr. Dekker said. “So if you have leadership who has a stigma against addiction treatment, you are going to have a steep incline to work against, whereas if you have leadership that were, I would say, endowed with a different sense of knowledge and experience,” there is a much greater chance for helping both military service members and veterans alike.

He called on the US Department of Veterans Affairs (VA) to look more closely at how it is prescribing opioids. While acknowledging the opioid addiction epidemic, he noted that simply cutting back on prescribing may not be the right solution because it is having a ripple effect and causing other problems, namely that although the VA has written 60% fewer opioid prescriptions from 2012 to 2019, overdose rates have doubled as military members and veterans are seeking opioids from other sources outside of a controlled, safer medical environment.

It can be especially problematic for those who have a legitimate medical need for opioids but have a disqualifying event that causes the pain medication to be cut off.

“We need to have a different answer to this because termination of opioids because a patient is positive for marijuana or even positive for cocaine doesn’t mean you take services away. You ramp services up,” Dr. Dekker said. “If I have a patient who has a chronic pain syndrome, the only thing that is going to push him out of my system is if they threaten my staff.…The loss from recovery is not a reason to lose treatment. That is another concept that needs to be addressed and we need to really look at that.”

He also called on VA leadership to be more encouraging in prescribing buprenorphine, noting that many doctors and nurses have waivers to prescribe it, but there is a lot of reluctance to do so, even though there is a lot of success with that treatment.

One theme emerged from multiple military healthy system (MHS) leaders at the recent AMSUS annual conference: Significant change is coming to the MHS, and military health care providers can either embrace and shape that change or somebody else will. “If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs; Defense Health Agency (DHA), and the Uniformed Service University for the Health Sciences (USU) told the audience.

The “historic” changes are underway, as the DHA has already begun to take over control of many military treatment facilities (MTFs) that were formerly operated by the separate services. In the next step of the transition, nearly 250 individual MTFs will be combined—along with TRICARE providers—in 21 geographically based “markets” in order to streamline management and avoid redundancies.

The exact details of the changes in store have not been released. McCaffrey noted that US Department of Defense (DoD) leadership will submit the “framework” for their assessment of the MHS to Congress “very soon, and at that point we will begin the hard work of detailed implementation of the results of that assessment and recommendations from the department.” Changes are expected to continue through fiscal year 2021, and some sources have estimated that as many as 18,000 jobs could be eliminated in the process.

Although Congress drove these changes in the National Defense Authorization Act of 2017, MHS leaders insist they are determining how to make the transformation without hurting medical readiness. “We the senior leadership of the MHS must continue to work together to shape our system to meet the challenges of the new environment,” McCaffrey insisted.

It seems as though all elements of the MHS are on the table. One report has suggested that the USU budget could be cut by a third. “Given the USU’s track record of excellence, we were alarmed to learn that the department is considering cuts as high as 30% to the university’s budget for research, development, testing, and evaluation, and 34% to university operations and maintenance... includ[ing] the cancellation of a $445 million military construction project and closure of the USU medical school,” US senators Chris Van Hollen (D-MD), Ben Cardin (D-MD.), Jack Reed (D-RI), and Congressman Jamie Raskin (D-MD) wrote in a November 21, 2019, letter to US Department of Defense Secretary Mark Esper. “These cuts, even if only partially implemented or scaled back, will adversely impact the enterprise across recruitment, retention, access to research funding, and severely impact medical readiness at a time when demand is increasing.”

The medical readiness of military health care providers remains one of the thorniest challenges revolving around the DHA transition. “As an infantryman, from my perspective if you can't maintain effectiveness on the trauma side than it is not worth getting more efficient,” argued LTG (Ret) Jeffrey S. Buchannon, who formerly served as senior commander of Fort Sam Houston, which includes Brooke Army Medical Center, the military’s only level 1 trauma center and 1 of only 2 trauma centers in San Antonio. “We need the home game in order to prepare for the away game,”

In its review, DoD is looking at how the MTFs support inpatient and/or outpatient services to maintain medical force readiness. “We need to identify those areas where we can expand capacity at MTFs that offer potential for sustaining the skills and knowledge of our members,” said McCaffrey. “But we also must examine those areas where facilities do not offer now and likely will not be able to offer in the future a platform for maximizing capabilities to support medical readiness. In those situations, we must be open to right sizing MTF services and capabilities so as to ensure that we are using finite resources most efficiently while not compromising our ability to meet the mission.”

“Our military healthy system is the envy of the world. Any great power competitor would trade its health care and battlefield medicine capabilities for the system you have built,” McCaffrey said. “But just as America’s combat supremacy is not guaranteed nor is the supremacy of the MHS.” The US faces new global security challenges, McCaffrey argued, and “we must adapt and evolve if we are to successfully meet these challenges.”

One theme emerged from multiple military healthy system (MHS) leaders at the recent AMSUS annual conference: Significant change is coming to the MHS, and military health care providers can either embrace and shape that change or somebody else will. “If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs; Defense Health Agency (DHA), and the Uniformed Service University for the Health Sciences (USU) told the audience.

The “historic” changes are underway, as the DHA has already begun to take over control of many military treatment facilities (MTFs) that were formerly operated by the separate services. In the next step of the transition, nearly 250 individual MTFs will be combined—along with TRICARE providers—in 21 geographically based “markets” in order to streamline management and avoid redundancies.

The exact details of the changes in store have not been released. McCaffrey noted that US Department of Defense (DoD) leadership will submit the “framework” for their assessment of the MHS to Congress “very soon, and at that point we will begin the hard work of detailed implementation of the results of that assessment and recommendations from the department.” Changes are expected to continue through fiscal year 2021, and some sources have estimated that as many as 18,000 jobs could be eliminated in the process.

Although Congress drove these changes in the National Defense Authorization Act of 2017, MHS leaders insist they are determining how to make the transformation without hurting medical readiness. “We the senior leadership of the MHS must continue to work together to shape our system to meet the challenges of the new environment,” McCaffrey insisted.

It seems as though all elements of the MHS are on the table. One report has suggested that the USU budget could be cut by a third. “Given the USU’s track record of excellence, we were alarmed to learn that the department is considering cuts as high as 30% to the university’s budget for research, development, testing, and evaluation, and 34% to university operations and maintenance... includ[ing] the cancellation of a $445 million military construction project and closure of the USU medical school,” US senators Chris Van Hollen (D-MD), Ben Cardin (D-MD.), Jack Reed (D-RI), and Congressman Jamie Raskin (D-MD) wrote in a November 21, 2019, letter to US Department of Defense Secretary Mark Esper. “These cuts, even if only partially implemented or scaled back, will adversely impact the enterprise across recruitment, retention, access to research funding, and severely impact medical readiness at a time when demand is increasing.”

The medical readiness of military health care providers remains one of the thorniest challenges revolving around the DHA transition. “As an infantryman, from my perspective if you can't maintain effectiveness on the trauma side than it is not worth getting more efficient,” argued LTG (Ret) Jeffrey S. Buchannon, who formerly served as senior commander of Fort Sam Houston, which includes Brooke Army Medical Center, the military’s only level 1 trauma center and 1 of only 2 trauma centers in San Antonio. “We need the home game in order to prepare for the away game,”

In its review, DoD is looking at how the MTFs support inpatient and/or outpatient services to maintain medical force readiness. “We need to identify those areas where we can expand capacity at MTFs that offer potential for sustaining the skills and knowledge of our members,” said McCaffrey. “But we also must examine those areas where facilities do not offer now and likely will not be able to offer in the future a platform for maximizing capabilities to support medical readiness. In those situations, we must be open to right sizing MTF services and capabilities so as to ensure that we are using finite resources most efficiently while not compromising our ability to meet the mission.”

“Our military healthy system is the envy of the world. Any great power competitor would trade its health care and battlefield medicine capabilities for the system you have built,” McCaffrey said. “But just as America’s combat supremacy is not guaranteed nor is the supremacy of the MHS.” The US faces new global security challenges, McCaffrey argued, and “we must adapt and evolve if we are to successfully meet these challenges.”

One theme emerged from multiple military healthy system (MHS) leaders at the recent AMSUS annual conference: Significant change is coming to the MHS, and military health care providers can either embrace and shape that change or somebody else will. “If we don’t shape our future, others will step in and do it for us,” Tom McCaffrey, Assistant Secretary of Defense for Health Affairs; Defense Health Agency (DHA), and the Uniformed Service University for the Health Sciences (USU) told the audience.

The “historic” changes are underway, as the DHA has already begun to take over control of many military treatment facilities (MTFs) that were formerly operated by the separate services. In the next step of the transition, nearly 250 individual MTFs will be combined—along with TRICARE providers—in 21 geographically based “markets” in order to streamline management and avoid redundancies.

The exact details of the changes in store have not been released. McCaffrey noted that US Department of Defense (DoD) leadership will submit the “framework” for their assessment of the MHS to Congress “very soon, and at that point we will begin the hard work of detailed implementation of the results of that assessment and recommendations from the department.” Changes are expected to continue through fiscal year 2021, and some sources have estimated that as many as 18,000 jobs could be eliminated in the process.

Although Congress drove these changes in the National Defense Authorization Act of 2017, MHS leaders insist they are determining how to make the transformation without hurting medical readiness. “We the senior leadership of the MHS must continue to work together to shape our system to meet the challenges of the new environment,” McCaffrey insisted.

It seems as though all elements of the MHS are on the table. One report has suggested that the USU budget could be cut by a third. “Given the USU’s track record of excellence, we were alarmed to learn that the department is considering cuts as high as 30% to the university’s budget for research, development, testing, and evaluation, and 34% to university operations and maintenance... includ[ing] the cancellation of a $445 million military construction project and closure of the USU medical school,” US senators Chris Van Hollen (D-MD), Ben Cardin (D-MD.), Jack Reed (D-RI), and Congressman Jamie Raskin (D-MD) wrote in a November 21, 2019, letter to US Department of Defense Secretary Mark Esper. “These cuts, even if only partially implemented or scaled back, will adversely impact the enterprise across recruitment, retention, access to research funding, and severely impact medical readiness at a time when demand is increasing.”

The medical readiness of military health care providers remains one of the thorniest challenges revolving around the DHA transition. “As an infantryman, from my perspective if you can't maintain effectiveness on the trauma side than it is not worth getting more efficient,” argued LTG (Ret) Jeffrey S. Buchannon, who formerly served as senior commander of Fort Sam Houston, which includes Brooke Army Medical Center, the military’s only level 1 trauma center and 1 of only 2 trauma centers in San Antonio. “We need the home game in order to prepare for the away game,”

In its review, DoD is looking at how the MTFs support inpatient and/or outpatient services to maintain medical force readiness. “We need to identify those areas where we can expand capacity at MTFs that offer potential for sustaining the skills and knowledge of our members,” said McCaffrey. “But we also must examine those areas where facilities do not offer now and likely will not be able to offer in the future a platform for maximizing capabilities to support medical readiness. In those situations, we must be open to right sizing MTF services and capabilities so as to ensure that we are using finite resources most efficiently while not compromising our ability to meet the mission.”

“Our military healthy system is the envy of the world. Any great power competitor would trade its health care and battlefield medicine capabilities for the system you have built,” McCaffrey said. “But just as America’s combat supremacy is not guaranteed nor is the supremacy of the MHS.” The US faces new global security challenges, McCaffrey argued, and “we must adapt and evolve if we are to successfully meet these challenges.”

NATIONAL HARBOR, MD—As the Military Health System is undergoing significant structural and eventually manpower changes, ADM Brett P. Giroir, MD, the Assistant Secretary for Health in the US Department of Health and Human Services (HHS) and the US Food and Drug Administration acting commissioner, had one message: Come and join us. “Recruitment and retention are our top priorities,” ADM Giroir told the largely military health care provider audience, “If there is downsizing of any of the military health [system], we want you. If you touch health in any way…we need great people who are committed to our national goals in the Commissioned Corps.”

Not long ago, the US Public Health Service (PHS) was facing its own pressures to either reduce its workforce or to eliminate the PHS Commissioned Corps altogether. “The Corps’ mission assignments and functions have not evolved in step with the public health needs of the nation,” argued the fiscal year 2019 Office of Management and Budget, Budget of The U.S. Government. “It is time for that to change. HHS is committed to providing the best public health services and emergency response at the lowest cost and is undertaking a comprehensive look at how the Corps is structured.”

In response, PHS has undertaken a top-to-bottom audit and reevaluation of its mission, ADM Giroir noted, with the goal of defining the role for the PHS in the 21st century and beyond. As a result, the PHS recently completed the development of a modernization plan. The plan entails specifically managing the force to meet mission requirements, developing and training a Ready Reserve force, enhancing training and professional development for the Commissioned Corps, and updating and improving PHS systems and processes.

As a part of the modernization plan, ADM Giroir outlined projected growth plans for the Corps: an increase from the 6,400 regular Corps officers in FY 2018 to 7,725 by FY 2024 with an additional 2,500 Ready Reserve officers, to “minimally meet the mission requirements as we understand it,” ADM Giroir noted.

According to ADM Giroir, the goals for the Ready Reserve are an essential component in the PHS mission to meet any regional, national, or global public health emergency. The Ready Reserve would be a well-trained public health force that would be ready to deploy quickly. Whereas in the past, PHS officer deployments and specialties were tailored to the needs of the agencies in which they are embedded, this force would be more aligned with the needs for a rapid public health emergency response and would include specialized providers. In that context health care providers with military rapid response training would be highly valued.

Although the PHS has outlined its modernization plan, no budget has been allocated for it. Moreover, as ADM Giroir, has noted, PHS still remains dependent on the budgets of the embedding agencies to pay for the Commissioned Corps. “Right now our force structure is really determined by what federal agencies need,” he noted.

Currently, there are bills pending in both the House of Representatives and the Senate to codify the modernization effort.

NATIONAL HARBOR, MD—As the Military Health System is undergoing significant structural and eventually manpower changes, ADM Brett P. Giroir, MD, the Assistant Secretary for Health in the US Department of Health and Human Services (HHS) and the US Food and Drug Administration acting commissioner, had one message: Come and join us. “Recruitment and retention are our top priorities,” ADM Giroir told the largely military health care provider audience, “If there is downsizing of any of the military health [system], we want you. If you touch health in any way…we need great people who are committed to our national goals in the Commissioned Corps.”

Not long ago, the US Public Health Service (PHS) was facing its own pressures to either reduce its workforce or to eliminate the PHS Commissioned Corps altogether. “The Corps’ mission assignments and functions have not evolved in step with the public health needs of the nation,” argued the fiscal year 2019 Office of Management and Budget, Budget of The U.S. Government. “It is time for that to change. HHS is committed to providing the best public health services and emergency response at the lowest cost and is undertaking a comprehensive look at how the Corps is structured.”

In response, PHS has undertaken a top-to-bottom audit and reevaluation of its mission, ADM Giroir noted, with the goal of defining the role for the PHS in the 21st century and beyond. As a result, the PHS recently completed the development of a modernization plan. The plan entails specifically managing the force to meet mission requirements, developing and training a Ready Reserve force, enhancing training and professional development for the Commissioned Corps, and updating and improving PHS systems and processes.

As a part of the modernization plan, ADM Giroir outlined projected growth plans for the Corps: an increase from the 6,400 regular Corps officers in FY 2018 to 7,725 by FY 2024 with an additional 2,500 Ready Reserve officers, to “minimally meet the mission requirements as we understand it,” ADM Giroir noted.

According to ADM Giroir, the goals for the Ready Reserve are an essential component in the PHS mission to meet any regional, national, or global public health emergency. The Ready Reserve would be a well-trained public health force that would be ready to deploy quickly. Whereas in the past, PHS officer deployments and specialties were tailored to the needs of the agencies in which they are embedded, this force would be more aligned with the needs for a rapid public health emergency response and would include specialized providers. In that context health care providers with military rapid response training would be highly valued.

Although the PHS has outlined its modernization plan, no budget has been allocated for it. Moreover, as ADM Giroir, has noted, PHS still remains dependent on the budgets of the embedding agencies to pay for the Commissioned Corps. “Right now our force structure is really determined by what federal agencies need,” he noted.

Currently, there are bills pending in both the House of Representatives and the Senate to codify the modernization effort.

NATIONAL HARBOR, MD—As the Military Health System is undergoing significant structural and eventually manpower changes, ADM Brett P. Giroir, MD, the Assistant Secretary for Health in the US Department of Health and Human Services (HHS) and the US Food and Drug Administration acting commissioner, had one message: Come and join us. “Recruitment and retention are our top priorities,” ADM Giroir told the largely military health care provider audience, “If there is downsizing of any of the military health [system], we want you. If you touch health in any way…we need great people who are committed to our national goals in the Commissioned Corps.”

Not long ago, the US Public Health Service (PHS) was facing its own pressures to either reduce its workforce or to eliminate the PHS Commissioned Corps altogether. “The Corps’ mission assignments and functions have not evolved in step with the public health needs of the nation,” argued the fiscal year 2019 Office of Management and Budget, Budget of The U.S. Government. “It is time for that to change. HHS is committed to providing the best public health services and emergency response at the lowest cost and is undertaking a comprehensive look at how the Corps is structured.”

In response, PHS has undertaken a top-to-bottom audit and reevaluation of its mission, ADM Giroir noted, with the goal of defining the role for the PHS in the 21st century and beyond. As a result, the PHS recently completed the development of a modernization plan. The plan entails specifically managing the force to meet mission requirements, developing and training a Ready Reserve force, enhancing training and professional development for the Commissioned Corps, and updating and improving PHS systems and processes.

As a part of the modernization plan, ADM Giroir outlined projected growth plans for the Corps: an increase from the 6,400 regular Corps officers in FY 2018 to 7,725 by FY 2024 with an additional 2,500 Ready Reserve officers, to “minimally meet the mission requirements as we understand it,” ADM Giroir noted.

According to ADM Giroir, the goals for the Ready Reserve are an essential component in the PHS mission to meet any regional, national, or global public health emergency. The Ready Reserve would be a well-trained public health force that would be ready to deploy quickly. Whereas in the past, PHS officer deployments and specialties were tailored to the needs of the agencies in which they are embedded, this force would be more aligned with the needs for a rapid public health emergency response and would include specialized providers. In that context health care providers with military rapid response training would be highly valued.

Although the PHS has outlined its modernization plan, no budget has been allocated for it. Moreover, as ADM Giroir, has noted, PHS still remains dependent on the budgets of the embedding agencies to pay for the Commissioned Corps. “Right now our force structure is really determined by what federal agencies need,” he noted.

Currently, there are bills pending in both the House of Representatives and the Senate to codify the modernization effort.

Millennials, defined as those born between 1981 and 1996, currently comprise 15% of all active physicians in the US.^1,2 A recent survey found that nearly 4 of 5 US millennial physicians have a desire for cross-sectional work in areas beyond patient care, such as academic research, health care consulting, entrepreneurship, and health care administration.³

For employers and educators, a better understanding of these preferences, through consideration of the unique education and skill set of the millennial physician workforce, may lead to more effective recruitment of young physicians and improved health systems, avoiding a mismatch between health care provider skills and available jobs that can be costly for both employers and employees.⁴

This article describes how US millennial physicians are choosing to cross-train (obtaining multiple degrees and/or completing combined medical residency training) throughout undergraduate, medical, and graduate medical education. We also outline ways in which the current physician marketplace may not match the skills of this population and suggest some ways that health care organizations could capitalize on this trend toward more cross-trained personnel in order to effectively recruit and retain the next generation of physicians.

Millennial Education

Undergraduates

The number of interdisciplinary undergraduate majors increased by almost 250% from 1975 to 2000.⁵ In 2010, nearly 20% of US college students graduated with 2 majors, representing a 70% increase in double majors between 2001 and 2011.^6,7 One emerging category of interdisciplinary majors in US colleges is health humanities programs, which have quadrupled since 2000.⁸

Medical school applicants and matriculants reflect this trend. Whereas in 1994, only 19% of applicants to medical school held nonscience degrees, about one-third of applicants now hold such degrees.^9,10 We have found no aggregated data on double majors entering US medical schools, but public class profiles suggest that medical school matriculants mirror their undergraduate counterparts in their tendency to hold double majors. In 2016, for example, 15% of the incoming class at the University of Michigan Medical School was composed of double majors, increasing to over 25% in 2017.¹¹

Medical Students

Early dual-degree programs in undergraduate medical training were reserved for MD/PhD programs.¹² Most US MD/PhD programs (90 out of 151) now offer doctorates in social sciences, humanities, or other nontraditional fields of graduate medical study, reflecting a shift in interests of those seeking dual-degree training in undergraduate medical education.¹³ While only 3 MD/PhD programs in the 1970s included trainees in the social sciences, 17 such programs exist today.¹⁴

Interest in dual-degree programs offering master’s level study has also increased over the past decade. In 2017, 87 medical schools offered programs for students to pursue a master of public health (MPH) and 41 offered master of science degrees in various fields, up from 52 and 37 institutions, respectively in 2006.¹⁵ The number of schools offering combined training in nonscience fields has also grown, with 63 institutions now offering a master of business administration (MBA), nearly double the number offered in 2006.¹⁵ At some institutions more than 20% of students are earning a master’s degree or doctorate in addition to their MD degree.¹⁶

Residents

The authors found no documentation of US residency training programs, outside of those in the specialty of preventive medicine, providing trainees with formal opportunities to obtain an MBA or MPH prior to 2001.¹⁷ However, of the 510 internal medicine residency programs listed on the American Medical Association residency and fellowship database (freida.ama-assn.org), 45 identified as having established a pathway for residents to pursue an MBA, MPH, or PhD during residency.¹⁸

Over the past 20 years, combined residency programs have increased 49% (from 128 to 191), which is triple the 16% rate (1,350 to 1,562) of increase in programs in internal medicine, pediatrics, family medicine, psychiatry, and emergency medicine.^19,20 A 2009 moratorium on the creation of new combined residency programs in psychiatry and neurology was lifted in 2016and is likely to increase the rate of total combined programs.²¹

The Table shows the number of categorical and combined residency programs available in 1996 and in 2016. Over 2 decades, 17 new specialty combinations became available for residency training. While there were no combined training programs within these 17 new combinations in 1996,there were 66 programs with these combinations in 2016.^19,20

Although surgical specialties are notably absent from the list of combined residency options, likely due to the duration of surgical training, some surgical training programs do offer pathways that culminate in combined degrees,²² and a high number of surgery program directors agree that residents should receive formal training in business and practice management.²³

The Medical Job Market

Although today’s young physicians are cross-trained in multiple disciplines, the current job market may not directly match these skill sets. Of the 7,235 jobs listed by the New England Journal of Medicine (NEJM) career center (www.nejmcareercenter.org/jobs), only 54 were targeted at those with combined training, the majority of which were aimed at those trained in internal medicine/pediatrics. Of the combined specialties in the Table, formal positions were listed for only 6.²⁴ A search of nearly 1,500 federal medical positions on USAJOBS (www.usajobs.gov) found only 4 jobs that combined specialties, all restricted to internal medicine/pediatrics.²⁵ When searching for jobs containing the terms MBA, MPH, and public health there were only 8 such positions on NEJM and 7 on USAJOBS.^24,25 Although the totality of the medical marketplace may not be best encompassed by these sources, the authors believe NEJM and USAJOBS are somewhat representative of the opportunities for physicians in the US.

Medical jobs tailored to cross-trained physicians do not appear to have kept pace with the numbers of such specialists currently in medical school and residency training. Though millennials are cross-training in increasing numbers, we surmise that they are not doing so as a direct result of the job market.

Future Medicine

Regardless of the mismatch between cross-trained physicians and the current job market, millennials may be well suited for future health systems. In 2001, the National Academies of Sciences, Engineering and Medicine (NASEM) called for increasing interdisciplinary training and improving cross-functional team performance as a major goal for health care providers in twenty-first century health systems.²⁶ NASEM also recommended that academic medical centers develop medical leaders who can manage systems changes required to enhance health, a proposal supported by the fact that hospitals with medically trained CEOs outperform others.^27,28

Public Health 3.0, a federal initiative to improve and integrate public health efforts, also emphasizes cross-disciplinary teams and cross-sector partnerships,²⁹ while the Centers for Medicare and Medicaid Services (CMS) has incentivized the development of interprofessional health care teams.³⁰ While cross-training does not automatically connote interdisciplinary training, we believe that cross-training may reveal or develop an interdisciplinary mind-set that may support and embrace interdisciplinary performance. Finally, the US Department of Health and Human Services’ (HHS) Strategic Goals emphasize integrated care for vulnerable populations, something that cross-trained physicians may be especially poised to accomplish.³¹

A Path Forward

The education, training, and priorities of young physicians demonstrates career interests that diverge from mainstream, traditional options. Data provided herein describe the increasing rates at which millennial physicians are cross-training and have suggested that the current marketplace may not match the interests of this population. The ultimate question is where such cross-trained physicians fit into today’s (or tomorrow’s) health system?

It may be easiest to deploy cross-trained physicians in their respective clinical departments (eg, having a physician trained in internal medicine and pediatrics perform clinical duties in both a medicine department and a pediatrics department). But < 40% of dual-boarded physicians practice both specialties in which they’re trained, so other opportunities should be pursued.^32,33 One strategy may be to embrace the promise of interdisciplinary care, as supported by Public Health 3.0 and NASEM.^26,29 Our evidence may demonstrate that the interdisciplinary mind-set may be more readily evident in the millennial generation, and that this mind-set may improve interdisciplinary care.

As health is impacted both by direct clinical care as well as programs designed to address population health, cross-trained physicians may be better equipped to integrate aspects of clinical care spanning a variety of clinical fields as well as orchestrating programs designed to improve health at the population level. This mind-set may be best captured by organizations willing to adapt their medical positions to emphasize multidisciplinary training, skills, and capabilities. For example, a physician trained in internal medicine and psychiatry may have the unique training and skill-set to establish an integrated behavioral health clinic that crosses boundaries between traditional departments, emphasizing the whole health of the clinic’s population and not simply focusing on providing services of a particular specialty. Hiring cross-trained physicians throughout such a clinic may benefit the operations of the clinic and improve not only the services provided, but ultimately, the health of that clinic’s patients. By embracing cross-trained physicians, health care organizations and educators may better meet the needs of their employees, likely resulting in a more cost-effective investment for employers, employees, and the health system as a whole.⁴ Additionally, patient health may also improve.

There is evidence that cross-trained physicians are already likely to hold leadership positions compared with their categorically-trained counterparts, and this may reflect the benefits of an interdisciplinary mind-set.³³ Perhaps a cross-trained physician is more likely to see beyond standard, specialty-based institutional barriers and develop processes and programs designed for overall patient benefit. Leadership is a skill that many millennials clearly wish to enhance throughout their career.³⁴ Recruiting cross-trained physicians for leadership positions may reveal synergies between such training and an ability to lead health care organizations into the future.

Many millennial physicians are bringing a new set of skills into the medical marketplace. Health organizations should identify ways to recruit for these skills and deploy them within their systems in order to have more dedicated, engaged employees, more effective health systems, and ultimately, healthier patients.

Acknowledgments
Data from this analysis were presented at the 10th Consortium of Universities for Global Health conference in 2019.³⁵

Millennials, defined as those born between 1981 and 1996, currently comprise 15% of all active physicians in the US.^1,2 A recent survey found that nearly 4 of 5 US millennial physicians have a desire for cross-sectional work in areas beyond patient care, such as academic research, health care consulting, entrepreneurship, and health care administration.³

For employers and educators, a better understanding of these preferences, through consideration of the unique education and skill set of the millennial physician workforce, may lead to more effective recruitment of young physicians and improved health systems, avoiding a mismatch between health care provider skills and available jobs that can be costly for both employers and employees.⁴

This article describes how US millennial physicians are choosing to cross-train (obtaining multiple degrees and/or completing combined medical residency training) throughout undergraduate, medical, and graduate medical education. We also outline ways in which the current physician marketplace may not match the skills of this population and suggest some ways that health care organizations could capitalize on this trend toward more cross-trained personnel in order to effectively recruit and retain the next generation of physicians.

Millennial Education

Undergraduates

The number of interdisciplinary undergraduate majors increased by almost 250% from 1975 to 2000.⁵ In 2010, nearly 20% of US college students graduated with 2 majors, representing a 70% increase in double majors between 2001 and 2011.^6,7 One emerging category of interdisciplinary majors in US colleges is health humanities programs, which have quadrupled since 2000.⁸

Medical school applicants and matriculants reflect this trend. Whereas in 1994, only 19% of applicants to medical school held nonscience degrees, about one-third of applicants now hold such degrees.^9,10 We have found no aggregated data on double majors entering US medical schools, but public class profiles suggest that medical school matriculants mirror their undergraduate counterparts in their tendency to hold double majors. In 2016, for example, 15% of the incoming class at the University of Michigan Medical School was composed of double majors, increasing to over 25% in 2017.¹¹

Medical Students

Early dual-degree programs in undergraduate medical training were reserved for MD/PhD programs.¹² Most US MD/PhD programs (90 out of 151) now offer doctorates in social sciences, humanities, or other nontraditional fields of graduate medical study, reflecting a shift in interests of those seeking dual-degree training in undergraduate medical education.¹³ While only 3 MD/PhD programs in the 1970s included trainees in the social sciences, 17 such programs exist today.¹⁴

Interest in dual-degree programs offering master’s level study has also increased over the past decade. In 2017, 87 medical schools offered programs for students to pursue a master of public health (MPH) and 41 offered master of science degrees in various fields, up from 52 and 37 institutions, respectively in 2006.¹⁵ The number of schools offering combined training in nonscience fields has also grown, with 63 institutions now offering a master of business administration (MBA), nearly double the number offered in 2006.¹⁵ At some institutions more than 20% of students are earning a master’s degree or doctorate in addition to their MD degree.¹⁶

Residents

The authors found no documentation of US residency training programs, outside of those in the specialty of preventive medicine, providing trainees with formal opportunities to obtain an MBA or MPH prior to 2001.¹⁷ However, of the 510 internal medicine residency programs listed on the American Medical Association residency and fellowship database (freida.ama-assn.org), 45 identified as having established a pathway for residents to pursue an MBA, MPH, or PhD during residency.¹⁸

Over the past 20 years, combined residency programs have increased 49% (from 128 to 191), which is triple the 16% rate (1,350 to 1,562) of increase in programs in internal medicine, pediatrics, family medicine, psychiatry, and emergency medicine.^19,20 A 2009 moratorium on the creation of new combined residency programs in psychiatry and neurology was lifted in 2016and is likely to increase the rate of total combined programs.²¹

The Table shows the number of categorical and combined residency programs available in 1996 and in 2016. Over 2 decades, 17 new specialty combinations became available for residency training. While there were no combined training programs within these 17 new combinations in 1996,there were 66 programs with these combinations in 2016.^19,20

Although surgical specialties are notably absent from the list of combined residency options, likely due to the duration of surgical training, some surgical training programs do offer pathways that culminate in combined degrees,²² and a high number of surgery program directors agree that residents should receive formal training in business and practice management.²³

The Medical Job Market

Although today’s young physicians are cross-trained in multiple disciplines, the current job market may not directly match these skill sets. Of the 7,235 jobs listed by the New England Journal of Medicine (NEJM) career center (www.nejmcareercenter.org/jobs), only 54 were targeted at those with combined training, the majority of which were aimed at those trained in internal medicine/pediatrics. Of the combined specialties in the Table, formal positions were listed for only 6.²⁴ A search of nearly 1,500 federal medical positions on USAJOBS (www.usajobs.gov) found only 4 jobs that combined specialties, all restricted to internal medicine/pediatrics.²⁵ When searching for jobs containing the terms MBA, MPH, and public health there were only 8 such positions on NEJM and 7 on USAJOBS.^24,25 Although the totality of the medical marketplace may not be best encompassed by these sources, the authors believe NEJM and USAJOBS are somewhat representative of the opportunities for physicians in the US.

Medical jobs tailored to cross-trained physicians do not appear to have kept pace with the numbers of such specialists currently in medical school and residency training. Though millennials are cross-training in increasing numbers, we surmise that they are not doing so as a direct result of the job market.

Future Medicine

Regardless of the mismatch between cross-trained physicians and the current job market, millennials may be well suited for future health systems. In 2001, the National Academies of Sciences, Engineering and Medicine (NASEM) called for increasing interdisciplinary training and improving cross-functional team performance as a major goal for health care providers in twenty-first century health systems.²⁶ NASEM also recommended that academic medical centers develop medical leaders who can manage systems changes required to enhance health, a proposal supported by the fact that hospitals with medically trained CEOs outperform others.^27,28

Public Health 3.0, a federal initiative to improve and integrate public health efforts, also emphasizes cross-disciplinary teams and cross-sector partnerships,²⁹ while the Centers for Medicare and Medicaid Services (CMS) has incentivized the development of interprofessional health care teams.³⁰ While cross-training does not automatically connote interdisciplinary training, we believe that cross-training may reveal or develop an interdisciplinary mind-set that may support and embrace interdisciplinary performance. Finally, the US Department of Health and Human Services’ (HHS) Strategic Goals emphasize integrated care for vulnerable populations, something that cross-trained physicians may be especially poised to accomplish.³¹

A Path Forward

The education, training, and priorities of young physicians demonstrates career interests that diverge from mainstream, traditional options. Data provided herein describe the increasing rates at which millennial physicians are cross-training and have suggested that the current marketplace may not match the interests of this population. The ultimate question is where such cross-trained physicians fit into today’s (or tomorrow’s) health system?

It may be easiest to deploy cross-trained physicians in their respective clinical departments (eg, having a physician trained in internal medicine and pediatrics perform clinical duties in both a medicine department and a pediatrics department). But < 40% of dual-boarded physicians practice both specialties in which they’re trained, so other opportunities should be pursued.^32,33 One strategy may be to embrace the promise of interdisciplinary care, as supported by Public Health 3.0 and NASEM.^26,29 Our evidence may demonstrate that the interdisciplinary mind-set may be more readily evident in the millennial generation, and that this mind-set may improve interdisciplinary care.

As health is impacted both by direct clinical care as well as programs designed to address population health, cross-trained physicians may be better equipped to integrate aspects of clinical care spanning a variety of clinical fields as well as orchestrating programs designed to improve health at the population level. This mind-set may be best captured by organizations willing to adapt their medical positions to emphasize multidisciplinary training, skills, and capabilities. For example, a physician trained in internal medicine and psychiatry may have the unique training and skill-set to establish an integrated behavioral health clinic that crosses boundaries between traditional departments, emphasizing the whole health of the clinic’s population and not simply focusing on providing services of a particular specialty. Hiring cross-trained physicians throughout such a clinic may benefit the operations of the clinic and improve not only the services provided, but ultimately, the health of that clinic’s patients. By embracing cross-trained physicians, health care organizations and educators may better meet the needs of their employees, likely resulting in a more cost-effective investment for employers, employees, and the health system as a whole.⁴ Additionally, patient health may also improve.

There is evidence that cross-trained physicians are already likely to hold leadership positions compared with their categorically-trained counterparts, and this may reflect the benefits of an interdisciplinary mind-set.³³ Perhaps a cross-trained physician is more likely to see beyond standard, specialty-based institutional barriers and develop processes and programs designed for overall patient benefit. Leadership is a skill that many millennials clearly wish to enhance throughout their career.³⁴ Recruiting cross-trained physicians for leadership positions may reveal synergies between such training and an ability to lead health care organizations into the future.

Many millennial physicians are bringing a new set of skills into the medical marketplace. Health organizations should identify ways to recruit for these skills and deploy them within their systems in order to have more dedicated, engaged employees, more effective health systems, and ultimately, healthier patients.

Acknowledgments
Data from this analysis were presented at the 10th Consortium of Universities for Global Health conference in 2019.³⁵

Millennials, defined as those born between 1981 and 1996, currently comprise 15% of all active physicians in the US.^1,2 A recent survey found that nearly 4 of 5 US millennial physicians have a desire for cross-sectional work in areas beyond patient care, such as academic research, health care consulting, entrepreneurship, and health care administration.³

For employers and educators, a better understanding of these preferences, through consideration of the unique education and skill set of the millennial physician workforce, may lead to more effective recruitment of young physicians and improved health systems, avoiding a mismatch between health care provider skills and available jobs that can be costly for both employers and employees.⁴

This article describes how US millennial physicians are choosing to cross-train (obtaining multiple degrees and/or completing combined medical residency training) throughout undergraduate, medical, and graduate medical education. We also outline ways in which the current physician marketplace may not match the skills of this population and suggest some ways that health care organizations could capitalize on this trend toward more cross-trained personnel in order to effectively recruit and retain the next generation of physicians.

Millennial Education

Undergraduates

The number of interdisciplinary undergraduate majors increased by almost 250% from 1975 to 2000.⁵ In 2010, nearly 20% of US college students graduated with 2 majors, representing a 70% increase in double majors between 2001 and 2011.^6,7 One emerging category of interdisciplinary majors in US colleges is health humanities programs, which have quadrupled since 2000.⁸

Medical school applicants and matriculants reflect this trend. Whereas in 1994, only 19% of applicants to medical school held nonscience degrees, about one-third of applicants now hold such degrees.^9,10 We have found no aggregated data on double majors entering US medical schools, but public class profiles suggest that medical school matriculants mirror their undergraduate counterparts in their tendency to hold double majors. In 2016, for example, 15% of the incoming class at the University of Michigan Medical School was composed of double majors, increasing to over 25% in 2017.¹¹

Medical Students

Early dual-degree programs in undergraduate medical training were reserved for MD/PhD programs.¹² Most US MD/PhD programs (90 out of 151) now offer doctorates in social sciences, humanities, or other nontraditional fields of graduate medical study, reflecting a shift in interests of those seeking dual-degree training in undergraduate medical education.¹³ While only 3 MD/PhD programs in the 1970s included trainees in the social sciences, 17 such programs exist today.¹⁴

Interest in dual-degree programs offering master’s level study has also increased over the past decade. In 2017, 87 medical schools offered programs for students to pursue a master of public health (MPH) and 41 offered master of science degrees in various fields, up from 52 and 37 institutions, respectively in 2006.¹⁵ The number of schools offering combined training in nonscience fields has also grown, with 63 institutions now offering a master of business administration (MBA), nearly double the number offered in 2006.¹⁵ At some institutions more than 20% of students are earning a master’s degree or doctorate in addition to their MD degree.¹⁶

Residents

The authors found no documentation of US residency training programs, outside of those in the specialty of preventive medicine, providing trainees with formal opportunities to obtain an MBA or MPH prior to 2001.¹⁷ However, of the 510 internal medicine residency programs listed on the American Medical Association residency and fellowship database (freida.ama-assn.org), 45 identified as having established a pathway for residents to pursue an MBA, MPH, or PhD during residency.¹⁸

Over the past 20 years, combined residency programs have increased 49% (from 128 to 191), which is triple the 16% rate (1,350 to 1,562) of increase in programs in internal medicine, pediatrics, family medicine, psychiatry, and emergency medicine.^19,20 A 2009 moratorium on the creation of new combined residency programs in psychiatry and neurology was lifted in 2016and is likely to increase the rate of total combined programs.²¹

The Table shows the number of categorical and combined residency programs available in 1996 and in 2016. Over 2 decades, 17 new specialty combinations became available for residency training. While there were no combined training programs within these 17 new combinations in 1996,there were 66 programs with these combinations in 2016.^19,20

Although surgical specialties are notably absent from the list of combined residency options, likely due to the duration of surgical training, some surgical training programs do offer pathways that culminate in combined degrees,²² and a high number of surgery program directors agree that residents should receive formal training in business and practice management.²³

The Medical Job Market

Although today’s young physicians are cross-trained in multiple disciplines, the current job market may not directly match these skill sets. Of the 7,235 jobs listed by the New England Journal of Medicine (NEJM) career center (www.nejmcareercenter.org/jobs), only 54 were targeted at those with combined training, the majority of which were aimed at those trained in internal medicine/pediatrics. Of the combined specialties in the Table, formal positions were listed for only 6.²⁴ A search of nearly 1,500 federal medical positions on USAJOBS (www.usajobs.gov) found only 4 jobs that combined specialties, all restricted to internal medicine/pediatrics.²⁵ When searching for jobs containing the terms MBA, MPH, and public health there were only 8 such positions on NEJM and 7 on USAJOBS.^24,25 Although the totality of the medical marketplace may not be best encompassed by these sources, the authors believe NEJM and USAJOBS are somewhat representative of the opportunities for physicians in the US.

Medical jobs tailored to cross-trained physicians do not appear to have kept pace with the numbers of such specialists currently in medical school and residency training. Though millennials are cross-training in increasing numbers, we surmise that they are not doing so as a direct result of the job market.

Future Medicine

Regardless of the mismatch between cross-trained physicians and the current job market, millennials may be well suited for future health systems. In 2001, the National Academies of Sciences, Engineering and Medicine (NASEM) called for increasing interdisciplinary training and improving cross-functional team performance as a major goal for health care providers in twenty-first century health systems.²⁶ NASEM also recommended that academic medical centers develop medical leaders who can manage systems changes required to enhance health, a proposal supported by the fact that hospitals with medically trained CEOs outperform others.^27,28

Public Health 3.0, a federal initiative to improve and integrate public health efforts, also emphasizes cross-disciplinary teams and cross-sector partnerships,²⁹ while the Centers for Medicare and Medicaid Services (CMS) has incentivized the development of interprofessional health care teams.³⁰ While cross-training does not automatically connote interdisciplinary training, we believe that cross-training may reveal or develop an interdisciplinary mind-set that may support and embrace interdisciplinary performance. Finally, the US Department of Health and Human Services’ (HHS) Strategic Goals emphasize integrated care for vulnerable populations, something that cross-trained physicians may be especially poised to accomplish.³¹

A Path Forward

The education, training, and priorities of young physicians demonstrates career interests that diverge from mainstream, traditional options. Data provided herein describe the increasing rates at which millennial physicians are cross-training and have suggested that the current marketplace may not match the interests of this population. The ultimate question is where such cross-trained physicians fit into today’s (or tomorrow’s) health system?

It may be easiest to deploy cross-trained physicians in their respective clinical departments (eg, having a physician trained in internal medicine and pediatrics perform clinical duties in both a medicine department and a pediatrics department). But < 40% of dual-boarded physicians practice both specialties in which they’re trained, so other opportunities should be pursued.^32,33 One strategy may be to embrace the promise of interdisciplinary care, as supported by Public Health 3.0 and NASEM.^26,29 Our evidence may demonstrate that the interdisciplinary mind-set may be more readily evident in the millennial generation, and that this mind-set may improve interdisciplinary care.

As health is impacted both by direct clinical care as well as programs designed to address population health, cross-trained physicians may be better equipped to integrate aspects of clinical care spanning a variety of clinical fields as well as orchestrating programs designed to improve health at the population level. This mind-set may be best captured by organizations willing to adapt their medical positions to emphasize multidisciplinary training, skills, and capabilities. For example, a physician trained in internal medicine and psychiatry may have the unique training and skill-set to establish an integrated behavioral health clinic that crosses boundaries between traditional departments, emphasizing the whole health of the clinic’s population and not simply focusing on providing services of a particular specialty. Hiring cross-trained physicians throughout such a clinic may benefit the operations of the clinic and improve not only the services provided, but ultimately, the health of that clinic’s patients. By embracing cross-trained physicians, health care organizations and educators may better meet the needs of their employees, likely resulting in a more cost-effective investment for employers, employees, and the health system as a whole.⁴ Additionally, patient health may also improve.

There is evidence that cross-trained physicians are already likely to hold leadership positions compared with their categorically-trained counterparts, and this may reflect the benefits of an interdisciplinary mind-set.³³ Perhaps a cross-trained physician is more likely to see beyond standard, specialty-based institutional barriers and develop processes and programs designed for overall patient benefit. Leadership is a skill that many millennials clearly wish to enhance throughout their career.³⁴ Recruiting cross-trained physicians for leadership positions may reveal synergies between such training and an ability to lead health care organizations into the future.

Many millennial physicians are bringing a new set of skills into the medical marketplace. Health organizations should identify ways to recruit for these skills and deploy them within their systems in order to have more dedicated, engaged employees, more effective health systems, and ultimately, healthier patients.

Acknowledgments
Data from this analysis were presented at the 10th Consortium of Universities for Global Health conference in 2019.³⁵

High reliability organizations (HROs) incorporate continuous process improvement through leadership commitment to create a safety culture that works toward creating a zero-harm environment.¹ The Veterans Health Administration (VHA) has set transformational goals for becoming an HRO. In this article, we describe VIONE, an expanding medication deprescribing clinical program, which exemplifies the translation of HRO principles into health care system models. Both VIONE and HRO are globally relevant.

Reducing medication errors and related adverse drug events are important for achieving zero harm. Preventable medical errors rank behind heart disease and cancer as the third leading cause of death in the US.² The simultaneous use of multiple medications can lead to dangerous drug interactions, adverse outcomes, and challenges with adherence. When a person is taking multiple medicines, known as polypharmacy, it is more likely that some are potentially inappropriate medications (PIM). Current literature highlights the prevalence and dangers of polypharmacy, which ranks among the top 10 common causes of death in the US, as well as suggestions to address preventable adverse outcomes from polypharmacy and PIM.^3-5

Deprescribing of PIM frequently results in better disease management with improved health outcomes and quality of life.⁴ Many health care settings lack standardized approaches or set expectations to proactively deprescribe PIM. There has been insufficient emphasis on how to make decisions for deprescribing medications when therapeutic benefits are not clear and/or when the adverse effects may outweigh the therapeutic benefits.⁵

It is imperative to provide practice guidance for deprescribing nonessential medications along with systems-based infrastructure to enable integrated and effective assessments during opportune moments in the health care continuum. Multimodal approaches that include education, risk stratification, population health management interventions, research and resource allocation can help transform organizational culture in health care facilities toward HRO models of care, aiming at zero harm to patients.

The practical lessons learned from VIONE implementation science experiences on various scales and under diverse circumstances, cumulative wisdom from hindsight, foresight and critical insights gathered during nationwide spread of VIONE over the past 3 years continues to propel us toward the desirable direction and core concepts of an HRO.

The VIONE program facilitates practical, real-time interventions that could be tailored to various health care settings, organizational needs, and available resources. VIONE implements an electronic Computerized Patient Record System (CPRS) tool to enable planned cessation of nonessential medications that are potentially harmful, inappropriate, not indicated, or not necessary. The VIONE tool supports systematic, individualized assessment and adjustment through 5 filters (Figure 1). It prompts providers to assign 1 of these filters intuitively and objectively. VIONE combines clinical evidence for best practices, an interprofessional team approach, patient engagement, adapted use of existing medical records systems, and HRO principles for effective implementation.

As a tool to support safer prescribing practices, VIONE aligns closely with HRO principles (Table 1) and core pillars (Table 2).^6-8 A zero-harm safety culture necessitates that medications be used for correct reasons, over a correct duration of time, and following a correct schedule while monitoring for adverse outcomes. However, reality generally falls significantly short of this for a myriad of reasons, such as compromised health literacy, functional limitations, affordability, communication gaps, patients seen by multiple providers, and an accumulation of prescriptions due to comorbidities, symptom progression, and management of adverse effects. Through a sharpened focus on both precision medicine and competent prescription management, VIONE is a viable opportunity for investing in the zero-harm philosophy that is integral to an HRO.

Design and Implementation 

Initially launched in 2016 in a 15-bed inpatient, subacute rehabilitation unit within a VHA tertiary care facility, VIONE has been sustained and gradually expanded to 38 other VHA facility programs (Figure 2). Recognizing the potential value if adopted into widespread use, VIONE was a Gold Status winner in the VHA Under Secretary for Health Shark Tank-style competition in 2017 and was selected by the VHA Diffusion of Excellence as an innovation worthy of scale and spread through national dissemination.⁹ A toolkit for VIONE implementation, patient and provider brochures, VIONE vignette, and National Dialog template also have been created.¹⁰

Implementing VIONE in a new facility requires an actively engaged core team committed to patient safety and reduction of polypharmacy and PIM, interest and availability to lead project implementation strategies, along with meaningful local organizational support. The current structure for VIONE spread is as follows:

• Interested VHA participants review information and contact [email protected].
• The VIONE team orients implementing champions, mainly pharmacists, physicians, nurse practitioners, and physician assistants at a facility program level, offering guidance and available resources.
• Clinical Application Coordinators at Central Arkansas VA Healthcare System and participating facilities collaborate to add deprescribing menu options in CPRS and install the VIONE Polypharmacy Reminder Dialog template.
• Through close and ongoing collaborations, medical providers and clinical pharmacists proceed with deprescribing, aiming at planned cessation of nonessential and PIM, using the mnemonic prompt of VIONE. Vital and Important medications are continued and consolidated while a methodical plan is developed to deprescribe any medications that could lead to more harm than benefit and qualify based on the filters of Optional, Not indicated, and Every medicine has a diagnosis/reason. They select the proper discontinuation reasons in the CPRS medication menu (Figure 3) and document the rationale in the progress notes. It is highly encouraged that the collaborating pharmacists and health care providers add each other as cosigners and communicate effectively. Clinical pharmacy specialists also use the VIONE Polypharmacy Reminder Dialog Template (RDT) to document complete medication reviews with veterans to include deprescribing rationale and document shared decision making.

• A VIONE national dashboard captures deprescribing data in real time and automates reporting with daily updates that are readily accessible to all implementing facilities. Minimum data captured include the number of unique veterans impacted, number of medications deprescribed, cumulative cost avoidance to date, and number of prescriptions deprescribed per veteran. The dashboard facilitates real-time use of individual patient data and has also been designed to capture data from VHA administrative data portals and Corporate Data Warehouse.

Results

As of October 31, 2019, the assessment of polypharmacy using the VIONE tool across VHA sites has benefited > 60,000 unique veterans, of whom 49.2% were in urban areas, 47.7% in rural areas, and 3.1% in highly rural areas. Elderly male veterans comprised a clear majority. More than 128,000 medications have been deprescribed. The top classes of medications deprescribed are antihypertensives, over-the-counter medications, and antidiabetic medications. An annualized cost avoidance of > $4.0 million has been achieved. Cost avoidance is the cost of medications that otherwise would have continued to be filled and paid for by the VHA if they had not been deprescribed, projected for a maximum of 365 days. The calculation methodology can be summarized as follows:

The calculations reported in Table 3 and Figure 4 are conservative and include only chronic outpatient prescriptions and do not account for medications deprescribed in inpatient units, nursing home, community living centers, or domiciliary populations. Data tracked separately from inpatient and community living center patient populations indicated an additional 25,536 deprescribed medications, across 28 VA facilities, impacting 7,076 veterans with an average 2.15 medications deprescribed per veteran. The additional achieved cost avoidance was $370,272 (based on $14.50 average cost per prescription). Medications restarted within 30 days of deprescribing are not included in these calculations.

The cost avoidance calculation further excludes the effects of VIONE implementation on many other types of interventions. These interventions include, but are not limited to, changing from aggressive care to end of life, comfort care when strongly indicated; reduced emergency department visits or invasive diagnostic and therapeutic approaches, when not indicated; medical supplies, antimicrobial preparations; labor costs related to packaging, mailing, and administering prescriptions; reduced/prevented clinical waste; reduced decompensation of systemic illnesses and subsequent health care needs precipitated by iatrogenic disturbances and prolonged convalescence; and overall changes to prescribing practices through purposeful and targeted interactions with colleagues across various disciplines and various hierarchical levels.

Discussion

The VIONE clinical program exemplifies the translation of HRO principles into health care system practices. VIONE offers a systematic approach to improve medication management with an emphasis on deprescribing nonessential medications across various health care settings, facilitating VHA efforts toward zero harm. It demonstrates close alignment with the key building blocks of an HRO. Effective VIONE incorporation into an organizational culture reflects leadership commitment to safety and reliability in their vision and actions. By empowering staff to proactively reduce inappropriate medications and thereby prevent patient harm, VIONE contributes to enhancing an enterprise-wide culture of safety, with fewer errors and greater reliability. As a standardized decision support tool for the ongoing practice of assessment and planned cessation of potentially inappropriate medications, VIONE illustrates how continuous process improvement can be a part of staff-engaged, veteran-centered, highly reliable care. The standardization of the VIONE tool promotes achievement and sustainment of desired HRO principles and practices within health care delivery systems.

Conclusions

The VIONE program was launched not as a cost savings or research program but as a practical, real-time bedside or ambulatory care intervention to improve patient safety. Its value is reflected in the overwhelming response from scholarly and well-engaged colleagues expressing serious interests in expanding collaborations and tailoring efforts to add more depth and breadth to VIONE related efforts.

Acknowledgments
The authors express their gratitude to Central Arkansas VA Healthcare System leadership, Clinical Applications Coordinators, and colleagues for their unconditional support, to the Diffusion of Excellence programs at US Department of Veterans Affairs Central Office for their endorsement, and to the many VHA participants who renew our optimism and energy as we continue this exciting journey. We also thank Bridget B. Kelly for her assistance in writing and editing of the manuscript.

High reliability organizations (HROs) incorporate continuous process improvement through leadership commitment to create a safety culture that works toward creating a zero-harm environment.¹ The Veterans Health Administration (VHA) has set transformational goals for becoming an HRO. In this article, we describe VIONE, an expanding medication deprescribing clinical program, which exemplifies the translation of HRO principles into health care system models. Both VIONE and HRO are globally relevant.

Reducing medication errors and related adverse drug events are important for achieving zero harm. Preventable medical errors rank behind heart disease and cancer as the third leading cause of death in the US.² The simultaneous use of multiple medications can lead to dangerous drug interactions, adverse outcomes, and challenges with adherence. When a person is taking multiple medicines, known as polypharmacy, it is more likely that some are potentially inappropriate medications (PIM). Current literature highlights the prevalence and dangers of polypharmacy, which ranks among the top 10 common causes of death in the US, as well as suggestions to address preventable adverse outcomes from polypharmacy and PIM.^3-5

Deprescribing of PIM frequently results in better disease management with improved health outcomes and quality of life.⁴ Many health care settings lack standardized approaches or set expectations to proactively deprescribe PIM. There has been insufficient emphasis on how to make decisions for deprescribing medications when therapeutic benefits are not clear and/or when the adverse effects may outweigh the therapeutic benefits.⁵

It is imperative to provide practice guidance for deprescribing nonessential medications along with systems-based infrastructure to enable integrated and effective assessments during opportune moments in the health care continuum. Multimodal approaches that include education, risk stratification, population health management interventions, research and resource allocation can help transform organizational culture in health care facilities toward HRO models of care, aiming at zero harm to patients.

The practical lessons learned from VIONE implementation science experiences on various scales and under diverse circumstances, cumulative wisdom from hindsight, foresight and critical insights gathered during nationwide spread of VIONE over the past 3 years continues to propel us toward the desirable direction and core concepts of an HRO.

The VIONE program facilitates practical, real-time interventions that could be tailored to various health care settings, organizational needs, and available resources. VIONE implements an electronic Computerized Patient Record System (CPRS) tool to enable planned cessation of nonessential medications that are potentially harmful, inappropriate, not indicated, or not necessary. The VIONE tool supports systematic, individualized assessment and adjustment through 5 filters (Figure 1). It prompts providers to assign 1 of these filters intuitively and objectively. VIONE combines clinical evidence for best practices, an interprofessional team approach, patient engagement, adapted use of existing medical records systems, and HRO principles for effective implementation.

As a tool to support safer prescribing practices, VIONE aligns closely with HRO principles (Table 1) and core pillars (Table 2).^6-8 A zero-harm safety culture necessitates that medications be used for correct reasons, over a correct duration of time, and following a correct schedule while monitoring for adverse outcomes. However, reality generally falls significantly short of this for a myriad of reasons, such as compromised health literacy, functional limitations, affordability, communication gaps, patients seen by multiple providers, and an accumulation of prescriptions due to comorbidities, symptom progression, and management of adverse effects. Through a sharpened focus on both precision medicine and competent prescription management, VIONE is a viable opportunity for investing in the zero-harm philosophy that is integral to an HRO.

Design and Implementation 

Initially launched in 2016 in a 15-bed inpatient, subacute rehabilitation unit within a VHA tertiary care facility, VIONE has been sustained and gradually expanded to 38 other VHA facility programs (Figure 2). Recognizing the potential value if adopted into widespread use, VIONE was a Gold Status winner in the VHA Under Secretary for Health Shark Tank-style competition in 2017 and was selected by the VHA Diffusion of Excellence as an innovation worthy of scale and spread through national dissemination.⁹ A toolkit for VIONE implementation, patient and provider brochures, VIONE vignette, and National Dialog template also have been created.¹⁰

Implementing VIONE in a new facility requires an actively engaged core team committed to patient safety and reduction of polypharmacy and PIM, interest and availability to lead project implementation strategies, along with meaningful local organizational support. The current structure for VIONE spread is as follows:

• Interested VHA participants review information and contact [email protected].
• The VIONE team orients implementing champions, mainly pharmacists, physicians, nurse practitioners, and physician assistants at a facility program level, offering guidance and available resources.
• Clinical Application Coordinators at Central Arkansas VA Healthcare System and participating facilities collaborate to add deprescribing menu options in CPRS and install the VIONE Polypharmacy Reminder Dialog template.
• Through close and ongoing collaborations, medical providers and clinical pharmacists proceed with deprescribing, aiming at planned cessation of nonessential and PIM, using the mnemonic prompt of VIONE. Vital and Important medications are continued and consolidated while a methodical plan is developed to deprescribe any medications that could lead to more harm than benefit and qualify based on the filters of Optional, Not indicated, and Every medicine has a diagnosis/reason. They select the proper discontinuation reasons in the CPRS medication menu (Figure 3) and document the rationale in the progress notes. It is highly encouraged that the collaborating pharmacists and health care providers add each other as cosigners and communicate effectively. Clinical pharmacy specialists also use the VIONE Polypharmacy Reminder Dialog Template (RDT) to document complete medication reviews with veterans to include deprescribing rationale and document shared decision making.

• A VIONE national dashboard captures deprescribing data in real time and automates reporting with daily updates that are readily accessible to all implementing facilities. Minimum data captured include the number of unique veterans impacted, number of medications deprescribed, cumulative cost avoidance to date, and number of prescriptions deprescribed per veteran. The dashboard facilitates real-time use of individual patient data and has also been designed to capture data from VHA administrative data portals and Corporate Data Warehouse.

Results

As of October 31, 2019, the assessment of polypharmacy using the VIONE tool across VHA sites has benefited > 60,000 unique veterans, of whom 49.2% were in urban areas, 47.7% in rural areas, and 3.1% in highly rural areas. Elderly male veterans comprised a clear majority. More than 128,000 medications have been deprescribed. The top classes of medications deprescribed are antihypertensives, over-the-counter medications, and antidiabetic medications. An annualized cost avoidance of > $4.0 million has been achieved. Cost avoidance is the cost of medications that otherwise would have continued to be filled and paid for by the VHA if they had not been deprescribed, projected for a maximum of 365 days. The calculation methodology can be summarized as follows:

The calculations reported in Table 3 and Figure 4 are conservative and include only chronic outpatient prescriptions and do not account for medications deprescribed in inpatient units, nursing home, community living centers, or domiciliary populations. Data tracked separately from inpatient and community living center patient populations indicated an additional 25,536 deprescribed medications, across 28 VA facilities, impacting 7,076 veterans with an average 2.15 medications deprescribed per veteran. The additional achieved cost avoidance was $370,272 (based on $14.50 average cost per prescription). Medications restarted within 30 days of deprescribing are not included in these calculations.

The cost avoidance calculation further excludes the effects of VIONE implementation on many other types of interventions. These interventions include, but are not limited to, changing from aggressive care to end of life, comfort care when strongly indicated; reduced emergency department visits or invasive diagnostic and therapeutic approaches, when not indicated; medical supplies, antimicrobial preparations; labor costs related to packaging, mailing, and administering prescriptions; reduced/prevented clinical waste; reduced decompensation of systemic illnesses and subsequent health care needs precipitated by iatrogenic disturbances and prolonged convalescence; and overall changes to prescribing practices through purposeful and targeted interactions with colleagues across various disciplines and various hierarchical levels.

Discussion

The VIONE clinical program exemplifies the translation of HRO principles into health care system practices. VIONE offers a systematic approach to improve medication management with an emphasis on deprescribing nonessential medications across various health care settings, facilitating VHA efforts toward zero harm. It demonstrates close alignment with the key building blocks of an HRO. Effective VIONE incorporation into an organizational culture reflects leadership commitment to safety and reliability in their vision and actions. By empowering staff to proactively reduce inappropriate medications and thereby prevent patient harm, VIONE contributes to enhancing an enterprise-wide culture of safety, with fewer errors and greater reliability. As a standardized decision support tool for the ongoing practice of assessment and planned cessation of potentially inappropriate medications, VIONE illustrates how continuous process improvement can be a part of staff-engaged, veteran-centered, highly reliable care. The standardization of the VIONE tool promotes achievement and sustainment of desired HRO principles and practices within health care delivery systems.

Conclusions

The VIONE program was launched not as a cost savings or research program but as a practical, real-time bedside or ambulatory care intervention to improve patient safety. Its value is reflected in the overwhelming response from scholarly and well-engaged colleagues expressing serious interests in expanding collaborations and tailoring efforts to add more depth and breadth to VIONE related efforts.

Acknowledgments
The authors express their gratitude to Central Arkansas VA Healthcare System leadership, Clinical Applications Coordinators, and colleagues for their unconditional support, to the Diffusion of Excellence programs at US Department of Veterans Affairs Central Office for their endorsement, and to the many VHA participants who renew our optimism and energy as we continue this exciting journey. We also thank Bridget B. Kelly for her assistance in writing and editing of the manuscript.

High reliability organizations (HROs) incorporate continuous process improvement through leadership commitment to create a safety culture that works toward creating a zero-harm environment.¹ The Veterans Health Administration (VHA) has set transformational goals for becoming an HRO. In this article, we describe VIONE, an expanding medication deprescribing clinical program, which exemplifies the translation of HRO principles into health care system models. Both VIONE and HRO are globally relevant.

Reducing medication errors and related adverse drug events are important for achieving zero harm. Preventable medical errors rank behind heart disease and cancer as the third leading cause of death in the US.² The simultaneous use of multiple medications can lead to dangerous drug interactions, adverse outcomes, and challenges with adherence. When a person is taking multiple medicines, known as polypharmacy, it is more likely that some are potentially inappropriate medications (PIM). Current literature highlights the prevalence and dangers of polypharmacy, which ranks among the top 10 common causes of death in the US, as well as suggestions to address preventable adverse outcomes from polypharmacy and PIM.^3-5

Deprescribing of PIM frequently results in better disease management with improved health outcomes and quality of life.⁴ Many health care settings lack standardized approaches or set expectations to proactively deprescribe PIM. There has been insufficient emphasis on how to make decisions for deprescribing medications when therapeutic benefits are not clear and/or when the adverse effects may outweigh the therapeutic benefits.⁵

It is imperative to provide practice guidance for deprescribing nonessential medications along with systems-based infrastructure to enable integrated and effective assessments during opportune moments in the health care continuum. Multimodal approaches that include education, risk stratification, population health management interventions, research and resource allocation can help transform organizational culture in health care facilities toward HRO models of care, aiming at zero harm to patients.

The practical lessons learned from VIONE implementation science experiences on various scales and under diverse circumstances, cumulative wisdom from hindsight, foresight and critical insights gathered during nationwide spread of VIONE over the past 3 years continues to propel us toward the desirable direction and core concepts of an HRO.

The VIONE program facilitates practical, real-time interventions that could be tailored to various health care settings, organizational needs, and available resources. VIONE implements an electronic Computerized Patient Record System (CPRS) tool to enable planned cessation of nonessential medications that are potentially harmful, inappropriate, not indicated, or not necessary. The VIONE tool supports systematic, individualized assessment and adjustment through 5 filters (Figure 1). It prompts providers to assign 1 of these filters intuitively and objectively. VIONE combines clinical evidence for best practices, an interprofessional team approach, patient engagement, adapted use of existing medical records systems, and HRO principles for effective implementation.

As a tool to support safer prescribing practices, VIONE aligns closely with HRO principles (Table 1) and core pillars (Table 2).^6-8 A zero-harm safety culture necessitates that medications be used for correct reasons, over a correct duration of time, and following a correct schedule while monitoring for adverse outcomes. However, reality generally falls significantly short of this for a myriad of reasons, such as compromised health literacy, functional limitations, affordability, communication gaps, patients seen by multiple providers, and an accumulation of prescriptions due to comorbidities, symptom progression, and management of adverse effects. Through a sharpened focus on both precision medicine and competent prescription management, VIONE is a viable opportunity for investing in the zero-harm philosophy that is integral to an HRO.

Design and Implementation 

Initially launched in 2016 in a 15-bed inpatient, subacute rehabilitation unit within a VHA tertiary care facility, VIONE has been sustained and gradually expanded to 38 other VHA facility programs (Figure 2). Recognizing the potential value if adopted into widespread use, VIONE was a Gold Status winner in the VHA Under Secretary for Health Shark Tank-style competition in 2017 and was selected by the VHA Diffusion of Excellence as an innovation worthy of scale and spread through national dissemination.⁹ A toolkit for VIONE implementation, patient and provider brochures, VIONE vignette, and National Dialog template also have been created.¹⁰

Implementing VIONE in a new facility requires an actively engaged core team committed to patient safety and reduction of polypharmacy and PIM, interest and availability to lead project implementation strategies, along with meaningful local organizational support. The current structure for VIONE spread is as follows:

• Interested VHA participants review information and contact [email protected].
• The VIONE team orients implementing champions, mainly pharmacists, physicians, nurse practitioners, and physician assistants at a facility program level, offering guidance and available resources.
• Clinical Application Coordinators at Central Arkansas VA Healthcare System and participating facilities collaborate to add deprescribing menu options in CPRS and install the VIONE Polypharmacy Reminder Dialog template.
• Through close and ongoing collaborations, medical providers and clinical pharmacists proceed with deprescribing, aiming at planned cessation of nonessential and PIM, using the mnemonic prompt of VIONE. Vital and Important medications are continued and consolidated while a methodical plan is developed to deprescribe any medications that could lead to more harm than benefit and qualify based on the filters of Optional, Not indicated, and Every medicine has a diagnosis/reason. They select the proper discontinuation reasons in the CPRS medication menu (Figure 3) and document the rationale in the progress notes. It is highly encouraged that the collaborating pharmacists and health care providers add each other as cosigners and communicate effectively. Clinical pharmacy specialists also use the VIONE Polypharmacy Reminder Dialog Template (RDT) to document complete medication reviews with veterans to include deprescribing rationale and document shared decision making.

• A VIONE national dashboard captures deprescribing data in real time and automates reporting with daily updates that are readily accessible to all implementing facilities. Minimum data captured include the number of unique veterans impacted, number of medications deprescribed, cumulative cost avoidance to date, and number of prescriptions deprescribed per veteran. The dashboard facilitates real-time use of individual patient data and has also been designed to capture data from VHA administrative data portals and Corporate Data Warehouse.

Results

As of October 31, 2019, the assessment of polypharmacy using the VIONE tool across VHA sites has benefited > 60,000 unique veterans, of whom 49.2% were in urban areas, 47.7% in rural areas, and 3.1% in highly rural areas. Elderly male veterans comprised a clear majority. More than 128,000 medications have been deprescribed. The top classes of medications deprescribed are antihypertensives, over-the-counter medications, and antidiabetic medications. An annualized cost avoidance of > $4.0 million has been achieved. Cost avoidance is the cost of medications that otherwise would have continued to be filled and paid for by the VHA if they had not been deprescribed, projected for a maximum of 365 days. The calculation methodology can be summarized as follows:

The calculations reported in Table 3 and Figure 4 are conservative and include only chronic outpatient prescriptions and do not account for medications deprescribed in inpatient units, nursing home, community living centers, or domiciliary populations. Data tracked separately from inpatient and community living center patient populations indicated an additional 25,536 deprescribed medications, across 28 VA facilities, impacting 7,076 veterans with an average 2.15 medications deprescribed per veteran. The additional achieved cost avoidance was $370,272 (based on $14.50 average cost per prescription). Medications restarted within 30 days of deprescribing are not included in these calculations.

The cost avoidance calculation further excludes the effects of VIONE implementation on many other types of interventions. These interventions include, but are not limited to, changing from aggressive care to end of life, comfort care when strongly indicated; reduced emergency department visits or invasive diagnostic and therapeutic approaches, when not indicated; medical supplies, antimicrobial preparations; labor costs related to packaging, mailing, and administering prescriptions; reduced/prevented clinical waste; reduced decompensation of systemic illnesses and subsequent health care needs precipitated by iatrogenic disturbances and prolonged convalescence; and overall changes to prescribing practices through purposeful and targeted interactions with colleagues across various disciplines and various hierarchical levels.

Discussion

The VIONE clinical program exemplifies the translation of HRO principles into health care system practices. VIONE offers a systematic approach to improve medication management with an emphasis on deprescribing nonessential medications across various health care settings, facilitating VHA efforts toward zero harm. It demonstrates close alignment with the key building blocks of an HRO. Effective VIONE incorporation into an organizational culture reflects leadership commitment to safety and reliability in their vision and actions. By empowering staff to proactively reduce inappropriate medications and thereby prevent patient harm, VIONE contributes to enhancing an enterprise-wide culture of safety, with fewer errors and greater reliability. As a standardized decision support tool for the ongoing practice of assessment and planned cessation of potentially inappropriate medications, VIONE illustrates how continuous process improvement can be a part of staff-engaged, veteran-centered, highly reliable care. The standardization of the VIONE tool promotes achievement and sustainment of desired HRO principles and practices within health care delivery systems.

Conclusions

The VIONE program was launched not as a cost savings or research program but as a practical, real-time bedside or ambulatory care intervention to improve patient safety. Its value is reflected in the overwhelming response from scholarly and well-engaged colleagues expressing serious interests in expanding collaborations and tailoring efforts to add more depth and breadth to VIONE related efforts.

Acknowledgments
The authors express their gratitude to Central Arkansas VA Healthcare System leadership, Clinical Applications Coordinators, and colleagues for their unconditional support, to the Diffusion of Excellence programs at US Department of Veterans Affairs Central Office for their endorsement, and to the many VHA participants who renew our optimism and energy as we continue this exciting journey. We also thank Bridget B. Kelly for her assistance in writing and editing of the manuscript.